DRAFT REPORT FOR CONSULTATION: DO NOT REFERENCEICRP Ref 4836-8337-6684
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Annals of the ICRP

678ICRP PUBLICATION 1XX

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Diagnostic Reference Levels in Medical Imaging
Editor
C.H. CLEMENT
Associate Editor
N. HAMADA
Authors on behalf of ICRP
E. Vano, D.L. Miller, C. J. Martin, M.M. Rehani, K. Kang, M. Rosenstein,
P. Ortiz, S. Mattsson, R. Padovani, A. Rogers

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PUBLISHED FOR

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The International Commission on Radiological Protection

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by

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[SAGE logo]

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Please cite this issue as ‘ICRP, 201x. Diagnostic Reference Levels in Medical Imaging.
ICRP Publication 1XX Ann. ICRP 4X(X-X)’

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CONTENTS[Guest?] Editorial ................................................................................................................. 5	  Diagnostic reference levels in medical imaging .................................................................. 6	  PREFACE ............................................................................................................................ 7	  EXECUTIVE SUMMARY ................................................................................................. 9	
  1. Introduction ...................................................................................................................... 9	
  2. Diagnostic reference levels .............................................................................................. 9	
  3. DRL quantities and values ............................................................................................. 10	
  4. Local, national and regional DRLs ................................................................................ 11	
  5. Using DRLs for optimisation of protection ................................................................... 11	
  6. Considerations for paediatric examinations ................................................................... 12	
  REFERENCES................................................................................................................... 12	  GLOSSARY ...................................................................................................................... 13	
  1.	
   INTRODUCTION ........................................................................................................ 19	
  1.1.	
   Introduction .............................................................................................................. 19	
  1.2.	
   Historical perspective on terminology ..................................................................... 20	
  1.3.	
   History ...................................................................................................................... 20	
  1.4.	
   Effectiveness of DRLs ............................................................................................. 21	
  1.5.	
   Issues with the current use of DRLs ........................................................................ 22	
  1.6.	
   Rationale for this report ........................................................................................... 25	
  1.7.	
   Target Audience ....................................................................................................... 27	
  1.8.	
   Summary .................................................................................................................. 27	
  1.9.	
   References ................................................................................................................ 28	
  2.	
   CONSIDERATIONS IN CONDUCTING SURVEYS TO ESTABLISH DRLS ....... 32	
  2.1.	
   Introduction .............................................................................................................. 33	
  2.2.	
   Approach to setting DRL values .............................................................................. 35	
  2.3.	
   Survey considerations .............................................................................................. 37	
  2.4.	
   Procedure selection .................................................................................................. 43	
  2.5.	
   Data collection methods ........................................................................................... 44	
  2.6.	
   Determining DRL values ......................................................................................... 45	
  2.7.	
   Image quality............................................................................................................ 50	
  2.8.	
   References ................................................................................................................ 52	
  3.	
   RADIOGRAPHY AND DIAGNOSTIC FLUOROSCOPY ........................................ 57	
  3.1.	
  Radiography and diagnostic fluoroscopy examinations ............................................. 57	
  3.2.	
  DRL quantities for radiography .................................................................................. 59	
  3.3.	
  DRL quantities for fluoroscopy .................................................................................. 60	
  3.4.	
  Use of phantoms in radiography and fluoroscopy ...................................................... 60	
  3.5.	
  Mammography ............................................................................................................ 61	
  3.6.	
  Dental radiography ..................................................................................................... 63	
  3.7.	
  References................................................................................................................... 64	
  4.	
   INTERVENTIONAL PROCEDURES ........................................................................ 66	
  4.1.	
  Introduction................................................................................................................. 66	
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4.2.	
  Complexity analyses ................................................................................................... 67	
  4.3.	
  Data sets for interventional fluoroscopy procedures .................................................. 68	
  4.4.	
  Use of multiple DRL quantities for interventional fluoroscopy ................................. 69	
  4.5.	
  Interventional CT ........................................................................................................ 70	
  4.6.	
  References................................................................................................................... 71	
  5.	
   DIGITAL RADIOGRAPHY, CT, NUCLEAR MEDICINE, AND MULTIMODALITY
PROCEDURES .......................................................................................................... 78	
  5.1.	
  Digital radiography detectors ..................................................................................... 78	
  5.2.	
  DRLs in digital radiography ....................................................................................... 79	
  5.2.1.	
   DRL quantities.................................................................................................... 80	
  5.2.2.	
   Procedure selection ............................................................................................. 80	
  5.3.	
  Computed Tomography .............................................................................................. 80	
  5.3.1.	
   DRLs in CT ........................................................................................................ 80	
  5.3.2.	
   Considerations for DRL surveys in CT .............................................................. 81	
  5.3.3.	
   Cone-beam CT.................................................................................................... 83	
  5.4.	
  DRLs in planar and SPECT nuclear medicine imaging ............................................. 84	
  5.5.	
  Considerations for DRL surveys for nuclear medicine .............................................. 85	
  5.6.	
  Hybrid imaging (PET/CT, SPECT/CT and PET/MRI) .............................................. 86	
  5.6.1.	
   PET ..................................................................................................................... 87	
  5.6.2.	
   CT in PET/CT and SPECT/CT........................................................................... 88	
  5.7.	
  References................................................................................................................... 88	
  6.	
   PAEDIATRICS ............................................................................................................ 92	
  6.1.	
  Considerations relevant to paediatric DRLs ............................................................... 93	
  6.2.	
  Paediatric DRLs for CT .............................................................................................. 96	
  6.3.	
  Paediatric DRLs for radiography, nuclear medicine and interventional procedures .. 97	
  6.4.	
  References................................................................................................................... 98	
  7.	
   APPLICATION OF DRLS IN CLINICAL PRACTICE ........................................... 101	  7.1.	
  Patient audits of DRL quantities for x-ray examinations ......................................... 102	  7.1.1.	
   Setting up an audit programme in healthcare faciities ..................................... 104	
  
7.1.2.	
   Audits for dental radiography ........................................................................... 105	
  7.1.3.	
   Corrective action .............................................................................................. 106	  7.2.	
  Factors to consider if a DRL value is exceeded ....................................................... 107	  7.3.	
  Survey methodology ................................................................................................. 107	  7.4.	
  Equipment performance............................................................................................ 108	
  7.4.1.	
   Radiography and fluoroscopy........................................................................... 108	
  7.4.2.	
   CT ..................................................................................................................... 109	  7.4.3.	
   Nuclear medicine .............................................................................................. 111	  7.5.	
  Procedure protocols .................................................................................................. 111	
  7.5.1.	
   Radiography and fluoroscopy protocols ........................................................... 111	
  7.5.2.	
   CT protocols ..................................................................................................... 112	
  7.5.3.	
   Nuclear medicine protocols .............................................................................. 113	  7.6.	
  Operator skill ............................................................................................................ 113	  7.7.	
  Procedure complexity and case mix ......................................................................... 114	  7.8.	
  Outcome of the investigation .................................................................................... 115	
  
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7.9.	
  References................................................................................................................. 116	  8.	
   SUMMARY OF THE COMMISSION’S RECOMMENDATIONS ......................... 118	  8.1.	
  General ...................................................................................................................... 118	  8.2.	
  DRL quantities .......................................................................................................... 118	  8.3.	
  Use of median values of the DRL survey distribution ............................................. 120	  8.4.	
  DRL surveys ............................................................................................................. 120	  8.5.	
  Setting DRL values ................................................................................................... 121	  8.6.	
  DRLS for interventional procedures ......................................................................... 122	  8.7.	
  Paediatric DRLs ........................................................................................................ 122	  8.8.	
  Application of DRLs in clinical practice .................................................................. 123	  Annex A.	
  
PREVIOUS ICRP RECOMMENDATIONS ON DRLS ......................... 125	
  A.1. Introduction ............................................................................................................. 125	
  A.2. Existing ICRP guidance .......................................................................................... 126	
  A.3. Previous review of reference levels in medical imaging ........................................ 126	
  A.4. Underlying considerations ...................................................................................... 127	
  A.5. Advice on DRLs provided in ICRP (2001) ............................................................. 128	
  A.5.1.	
   Objective of a DRL .............................................................................................. 128	
  A.5.2.	
   Uses for a DRL .................................................................................................... 128	
  A.5.3.	
   Definitions and examples ..................................................................................... 129	
  A.5.4.	
   Note on fluoroscopically-guided interventional procedures ................................ 130	
  A.5.5.	
   Local flexibility in setting DRLs ......................................................................... 131	  A.6. References ............................................................................................................... 131	
  

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[Guest?] Editorial
TITLE OF EDITORIAL (SAME STYLE AS LEVEL A HEADINGS)
To be completed.
The average editorial occupies about 1½ page.
Under the editorial, there is a blank line and then the editor’s name in small capitals, rightjustified. Note that no address, affiliation, or e-mail/fax information should be given.
AUTHOR (S)

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Diagnostic reference levels in medical imaging

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ICRP Publication 1XX

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Approved by the Commission in Month 201X
Abstract-The International Commission on Radiological Protection (ICRP) first introduced
the term ‘diagnostic reference level’ (DRL) in Publication 73 (1996). The concept was
subsequently developed further, and practical guidance was provided in 2001. DRLs havebeen proven to be an effective tool that aids in optimisation of protection in the medical
exposure of patients for diagnostic and interventional procedures. However, with time it has
become evident that additional advice is needed. There are issues related to definitions of theterms used in previous guidance, determination of the values for DRLs, the appropriate
interval for re-evaluating and updating these values, appropriate use of DRLs in clinicalpractice, methods for practical application of this tool, and application of the DRL concept tonewer imaging technologies. This report is intended as a further source of information andguidance on these issues. Some terminology has been clarified. In addition, the report
recommends quantities for use as DRLs for various imaging modalities, and provides
information on use of DRLs for interventional procedures and in paediatric imaging. It
suggests modifications in the conduct of DRL surveys that take advantage of automatedreporting of radiation dose related quantities, and points out the importance of including
information on DRLs in training programmes for health care workers. The target audience forthis report is national, regional and local authorities, professional societies, facilities where
ionising radiation is used for medical purposes, and responsible staff within these facilities. A
full set of the Commission’s recommendations is provided.
© 201X ICRP. Published by SAGE.
Keywords: Diagnostic reference levels, patient doses, optimisation.
AUTHORS ON BEHALF OF ICRP
E. VANO, D.L. MILLER, C. J. MARTIN, M.M. REHANI, K. KANG, M. ROSENSTEIN,
P. ORTIZ, S. MATTSSON, R. PADOVANI, A. ROGERS

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PREFACE

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The measurement of quantities related to patient dose for optimisation of protection in
medical imaging with ionising radiation began more than half a century ago. Beginning in the
1950s, national surveys of such quantities for diagnostic x-ray examinations were performedin the United States and the United Kingdom. In the 1970s, the Nationwide Evaluation of XRay Trends (NEXT) surveys began in the United States and in the 1980s the National
Radiation Protection Board (NRPB, now Public Health England) surveys in the United
Kingdom measured entrance surface exposure either free-in-air or incident on the patient. The
results of these and similar surveys were the basis for recommendations for radiographic
technique and for levels of the quantities surveyed. These were first developed in the UnitedStates, then in the United Kingdom, and subsequently in Europe. These recommendations
were referred to variously as exposure guides, guideline doses, guidance levels (by theInternational Atomic Energy Agency), reference doses and, from 1996, as diagnostic
reference levels (DRLs) in the publications of the International Commission on RadiologicalProtection (ICRP). The European Commission included DRLs in a Directive on medical
exposures in 1997. In 2001, ICRP published a Supporting Guidance expanding the use of
DRLs to interventional radiology and giving further advice on flexibility in their selection andimplementation. The present report is the result of the work of a Working Party of ICRP
Committee 3, which was created during the annual meeting held in Bethesda, Maryland, USA,on 22-28 October 2011. Digital techniques and interventional procedures, and new combined
imaging techniques such as positron emission tomography-computed tomography (PET-CT)
require new and updated advice. Committee 3 realised that the proper use of DRLs was stillrather poor within the medical community. The target group for this report is medical
physicists, radiologists, nuclear medicine specialists, radiographers, industry, health andregulatory authorities.
The membership of the Working Party was as follows:
E. Vano (Chair)
D.L. Miller

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The corresponding members were:
S. Mattsson
A. Rogers

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C.J. Martin

K. Kang
M.M. Rehani

P. Ortiz López
M. Rosenstein

R. Padovani

The membership of Committee 3 during the period of preparation of this report was:(2009-2013)
E. Vañó (Chair)
M.R. Baeza

J.-M. Cosset (Vice-chair)
L.T. Dauer

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M.M. Rehani (Secretary)
I. Gusev

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J.W. Hopewell
S. Mattson
H. Ringertz
B. Yue1
2(2013-2017)
E. Vañó (Chair)
K. Applegate
S. Demeter
R. Loose
K.Å. Riklund
B. YueP-L. Khong
D.L. Miller
M. Rosenstein

P. Ortiz López
K. Åhlström Riklund
Y. Yonekura

D.L. Miller (Vice-chair)
M. Bourguignon
K. Kang
P. Ortiz López
P. Scalliet

M.M. Rehani (Secretary)
L.T. Dauer
P-L. Khong
C.J. Martin
Y. Yonekura

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EXECUTIVE SUMMARY

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1. Introduction

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(a) The Commission first introduced the term ‘diagnostic reference level’ (DRL) in
Publication 73 (ICRP, 1996). The concept was subsequently developed further, and practicaladvice was provided in ICRP (2001). This development and the 2001 advice are summarisedin Annex A.
(b) As the Commission stated in Publication 103, in medical exposures the principle of
optimisation of protection is implemented through the use of DRLs (ICRP, 2007). DRLs have
proven to be an effective tool that aids in optimisation of protection in the medical exposureof patients for diagnostic and interventional procedures. DRLs are not intended for use inradiation therapy.
(c) With time, it has become evident that additional advice is needed. There are issues
related to definitions of some of the terms used in previous guidance, determination of thevalues for DRLs, the appropriate interval for re-evaluating and updating these values,
appropriate use of DRLs in clinical practice, methods for practical application of this tool, andapplication of the concept to certain newer imaging technologies [e.g. dual-energy computed
tomography (CT), positron emission tomography (PET)/CT, single photon emission CT(SPECT)/CT, cone-beam CT, digital radiography, tomosynthesis].
(d) This report is intended as a further source of information and guidance on these issues.
Some terminology has been clarified. In addition, the report recommends radiation dosequantities for use as DRLs for various imaging modalities, provides information on use of
DRLs for interventional procedures and in paediatric imaging, points out common errors in
the determination and application of DRLs, suggests modifications in DRL surveys that takeadvantage of automated reporting of radiation dose related quantities, and points out theimportance of including information on DRLs in training programmes for health workers andin information for patients.
(e) The target audience for this report is national, regional and local authorities,
professional societies, facilities where ionising radiation is used for medical exposures, andresponsible staff within these facilities.
(f) A full set of the Commission’s recommendations is provided as the last chapter(Chapter 8) of this report. In addition, each chapter is preceded by a set of Main Points thatsummarise the principal concepts in that chapter. A limited summary of the most important
points and recommendations is presented below for the convenience of the reader.

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2. Diagnostic reference levels

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(g) The principles of justification and optimisation of protection are key andcomplementary radiological safety tenets. Diagnostic reference level (DRL) is theCommission’s term for a tool used to aid in optimisation of protection in the medical exposure
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of patients for diagnostic and interventional procedures. A DRL value is a selected level of aradiation dose quantity (a “DRL quantity”) for broadly defined types of equipment for typicalexaminations for groups of standard-sized patients or, in certain specific circumstances, astandard phantom. DRLs do not apply to individual patients. They are derived from anarbitrary threshold in a distribution of values obtained locally and collected nationally or
regionally. A DRL is a supplement to professional judgement and does not provide a dividing
line between good and bad medical practice. All individuals who have a role in subjecting apatient to a medical exposure should be familiar with DRLs as a tool for optimisation ofprotection.
(h) The application of DRLs is not sufficient, by itself, for optimisation of protection.
Optimisation is generally concerned with maintaining the quality of the diagnostic
information provided by the examination commensurate with the medical purpose while, atthe same time, seeking to reduce patient exposures to radiation to a level as low as reasonably
achievable. Image quality or, more generally, the diagnostic information provided by theexamination (including the effects of post-processing), must also be evaluated. Methods toachieve optimisation that encompass both DRLs and image quality evaluation should be
implemented. In some cases, optimisation may result in an increase in dose.
(i) Compliance with DRLs does not, by itself, indicate that the procedure is performed at
an optimised level with regard to the amount of radiation used. Therefore, the Commission
recognises that additional improvement can often be obtained by using the median value (the50th percentile) of the distribution of values of dose-related quantities used to set the nationalor regional DRL value, rather than the 75th percentile commonly used for the DRL value. The
median value of the distribution also provides guidance on when investigation of image
quality should be considered as a priority.

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3. DRL quantities and values

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(j) Radiation metrics used for DRLs should be appropriate to the imaging modality being
evaluated, should assess the amount of ionising radiation applied to perform a medical
imaging task, and should be easily measured or determined. When two imaging modalities areused for the same procedure (e.g. PET/CT, SPECT/CT), it is appropriate to set and present
DRLs for both modalities independently.
(k) The numerical value of the DRL should be tied to defined clinical and technicalrequirements for the selected medical imaging task. The Commission recommends setting
DRLs based on surveys of the DRL quantities for procedures performed on an appropriate
sample of patients. The use of phantoms is not sufficient in most cases, as when phantoms areused, the effects of operator performance are not taken into account. The numerical values of
DRLs are advisory. However, an authorised body may require implementation of the DRL
concept.
(l) DRL values are not static. As optimisation continues or hardware and software
improve, DRLs should be updated on a regular basis. When new imaging techniques are
introduced, an effort should be made to measure DRL quantities and set DRLs as soon as ispracticable.

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123(m) For interventional procedures, complexity of the procedure may be considered insetting DRLs and a multiplying factor for the DRL value (e.g. 2 or 3) may be appropriate formore complex cases of a procedure.

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4. Local, national and regional DRLs

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(n) Organisations responsible for different components of the tasks of collating data on
DRL quantities and setting DRLs should be identified in each country or region. The process
to set and update DRLs should be both flexible and dynamic. Flexibility is necessary forprocedures where few data are available (e.g. interventional procedures in paediatric patients),
or where data are available from only one or a few centres. A dynamic process is necessary toallow initial DRLs to be derived from these data while waiting for a wider survey to be
conducted.
(o) Data for determining national DRL values are obtained from surveys. Values of DRL
quantities from patient examinations are collected from at several different health facilities.
The 75th percentile value of the distribution of median values (the 50th percentile) of a DRL
quantity at healthcare facilities throughout a country is used as the ‘national DRL’.
(p) When national DRL values exist for many or most countries within a region (e.g. theEuropean Union), regional DRL values may be determined by using the median value of theavailable national DRL values.
(q) National and regional DRLs should be revised at regular intervals of 3-5 years, or more
frequently when substantial changes in technology, new imaging protocols or improved postprocessing of images become available.
(r) Since national DRLs require large surveys, which can require substantial effort toperform and analyse, they are not always as responsive to changes in technology. Where it isapparent that further optimisation is being achieved locally, ‘Local DRLs’ based on surveys
within that limited area might be introduced to further assist the optimisation process. One
example of their use is to account for the substantial dose reduction that could be achieved
through the introduction of digital radiography detectors into dental radiography. Anotherexample is the introduction of new methods for post-processing of images.

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(s) Median values of the DRL quantity for medical imaging procedures for a specific x-ray
room or for a radiology department or other facility should be compared with DRL values to
identify whether the data for the location are substantially higher or lower than might be
anticipated.
(t) A DRL is considered to be exceeded when the median value of the DRL quantity for arepresentative sample of standard-sized patients at a facility is greater than the local or
national DRL value.
(u) If a DRL value for any procedure is exceeded, an investigation should be undertaken
without undue delay to determine possible reasons, and a corrective action plan should be
implemented and documented.
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12(v) DRLs are not intended to be used for individual patients or as trigger (alert or alarm)
levels for individual patients or individual examinations. Also, DRL values are not limits.

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6. Considerations for paediatric examinations

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(w) The amount of administered radiation for examinations of children can varytremendously due to the great variation in patient size and weight. This variation in patientradiation dose is appropriate. Variation in patient radiation dose is not appropriate if it is due
to failure to adapt the imaging protocol to account for paediatric diseases and paediatricpatient sizes.
(x) Appropriate weight bands (generally with 10 kg intervals) are recommended forestablishing paediatric DRLs and should be promoted for paediatrics.

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REFERENCES

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ICRP, 1996. Radiological protection and safety in medicine. ICRP Publication 73. Ann. ICRP
26(2).

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ICRP, 2001. International Commission on Radiological Protection. Diagnostic reference
levels in medical imaging: Review and additional advice. ICRP Supporting Guidance 2.
Ann. ICRP 31(4).

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ICRP, 2007. The 2007 Recommendations of the International Commission on RadiologicalProtection. ICRP publication 103. Ann. ICRP 37(2–4).

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GLOSSARY

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Air kerma-area product (PKA)
The integral of the air-kerma free-in-air (i.e. in the absence of backscatter) over thearea of the x-ray beam in a plane perpendicular to the beam axis. In many medical
publications, the acronym used for this quantity is KAP. The older terminology isdose-area product (DAP).
Air kerma at the patient entrance reference point (Ka,r)The air kerma at a point in space located at a fixed distance from the focal spot (seepatient entrance reference point) expressed in gray. The International ElectrotechnicalCommission (IEC, 2010) refers to this quantity as reference air kerma. The U.S. Foodand Drug Administration calls it cumulative air kerma. The International Commission
on Radiation Units and Measurements (ICRU) has not defined a symbol for thisquantity — Ka,r is the notation introduced by the National Council on Radiation
Protection and Measurements (NCRP) in Report No. 168 (NCRP, 2010). In many
medical publications, the acronym used for this quantity is CAK. This quantity isreferred to in older medical publications as cumulative dose, and has also been calledreference air kerma and reference point air kerma.
Computed tomography dose index (volume) (CTDIvol)
The weighted CTDI, CTDIw, normalised by the helical pitch. The weighted CTDIw is
an estimate of the average dose over a single slice in a CT dosimetry phantom. See
ICRU Report 87 (2012).
Constancy testing
A form of quality control (QC) testing that evaluates the current state of equipment
performance and image quality at regular intervals in time.
Cumulative air kerma
See Air kerma at the patient entrance reference point.
Deterministic effectSee Tissue reaction.
Detriment
The total harm to health experienced by an exposed group and its descendants as aresult of the group’s exposure to a radiation source. Detriment is a multidimensional
concept. Its principal components are the stochastic quantities: probability of
attributable fatal cancer, weighted probability of attributable non-fatal cancer,
weighted probability of severe heritable effects, and potential years of life lost if theharm occurs.

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Diagnostic reference level (DRL)A diagnostic reference level is a tool used to aid in optimisation of protection in the
medical exposure of patients for diagnostic and interventional procedures. It is used in
medical imaging with ionising radiation to indicate whether, in routine conditions, thepatient dose or administered activity (amount of radioactive material) from a specified
procedure is unusually high or low for that procedure. Also see DRL quantity.
Dose (ionising radiation)
A general term used when the context is not specific to a particular dosimetric quantity
related to the exposure of an individual to ionising radiation. When the context is
specific, the name or symbol for the dosimetric quantity is used.
Dose length product (DLP)
A parameter used as a surrogate measure for energy imparted to the patient in a CT
scan of length L. By convention, the DLP is reported in the units of mGy cm. See
ICRU Report 87 (2012) for more details.
DRL quantity
A commonly and easily measured or determined radiation dose quantity or metric (e.g.
Ka,e, Ka,i, CTDIvol, DLP, PKA, Ka,r, DG) that assesses the amount of ionising radiation
used to perform a medical imaging task. The quantity or quantities selected are thosethat are readily available for each type of medical imaging modality and medical
imaging task. Suitable quantities for medical imaging modalities and tasks are
identified in this publication. With the single exception of mean breast glandular dose
(DG) for mammography, these quantities are not the tissue or organ doses received by
the patient or quantities derived from such doses, which cannot be measured or easily
determined.
DRL value
A selected numerical value of a DRL quantity, set at the 75th percentile of the mediansof DRL quantity distributions observed at multiple facilities or in some specific cases,
the 75th percentile of the DRL quantity distributions observed at one or more local
healthcare facilities. Regional DRL values can also be based on the median values of
the available national DRLs.
Entrance-surface air kerma (Ka,e)
Air kerma on the central x-ray beam axis at the point where the x-ray beam enters thepatient or phantom (includes backscattered radiation). In many medical publications,the acronym used for this quantity is ESAK.
Incident air kerma (Ka,i)

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Air kerma from the incident beam on the central x-ray beam axis at the focal-spot-tosurface distance (does not include backscattered radiation). In many medical
publications, the acronym used for this quantity is IAK.
Kerma, (K)The quotient of the sum of the kinetic energies, dEtr, of all charged particles liberated
by uncharged particles in a mass dm of material, and the mass dm of that material.

The unit for kerma is joule per kilogramme (J kg-1). This unit’s special name is gray(Gy) (ICRP, 2007). “Kerma” is an acronym for kinetic energy released in a mass.
Local diagnostic reference level
A DRL set in a particular healthcare facility or several local healthcare facilities fordefined clinical imaging tasks. Also see “DRL value”.
Mean glandular dose (DG)
In mammography, DG is the mean absorbed dose in the glandular tissue of the breast,
where glandular tissue is the radiosensitive tissue of the breast. DG is calculated fromeither the Ka,i or the Ka,e used for the specific mammography examination. The
conversion from Ka,i to DG is a function of beam quality [i.e. half value layer (HVL)],
anode material, filtration, breast thickness and breast composition. The conversion
from Ka,e to DG is a function of all these factors as well as adjustment for thebackscatter factor from breast tissue. DG is also called average glandular dose (AGD).
Medical exposure
Exposure incurred by patients as part of their own medical or dental diagnosis ortreatment; by persons, other than those occupationally exposed, knowingly, while
voluntarily helping in the support and comfort of patients; and by volunteers in a
programme of biomedical research involving their exposure.
National diagnostic reference levels
DRLs set in a country based on data from a representative sample of healthcare
facilities in that country. Also see “DRL value”.
Notification Value
A component of the National Electrical Manufacturers Association (NEMA)
Computed Tomography (CT) Dose Check standard (XR 25) (NEMA, 2010). CT
scanners that are compliant with this standard will notify the operator prior to startinga scan whenever the estimated dose index is above a facility-defined value for volume
CT dose index (CTDIvol) or dose-length product (DLP) for a specific scan protocol (i.e.
either metric may be chosen by the facility). If the Notification Value is exceeded, a

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warning is displayed on the operator’s console that prompts the radiographer to review
the scan settings before proceeding with the examination, and either verify that they
are correct or change them.
Patient entrance reference point
The position at which the cumulative air kerma for interventional x-ray equipment ismeasured, in order to reasonably represent the air kerma incident on the patient’s skinsurface. For isocentric fluoroscopes (C-arms), the patient entrance reference point isdefined (IEC, 2010) as lying on the central axis of the x-ray beam, 15 cm on the x-ray
tube side of isocentre.
Peak skin dose (Dskin,max)
The maximum absorbed dose to the most heavily irradiated localised region of skin(i.e. the localised region of skin that lies within the primary x-ray beam for the longest
period of time during a fluoroscopically guided procedure). The notation
recommended by ICRU for the mean absorbed dose in a localised region of skin is
Dskin,local (ICRU, 2005). The notation used by NCRP for the maximum absorbed doseto the most heavily irradiated localised region of skin is Dskin,max (NCRP, 2010). Peakskin dose is measured in units of Gy (NCRP, 2010).
Radiation detrimentSee detriment
Reference phantom
Computational anthropomorphic phantom based on medical tomographic images
where the anatomy is described by small three-dimensional volume elements (voxels)
that specify the density and the atomic composition of the various organs and tissuesof the human body. ICRP phantoms are available for adult male and female humanbodies.
Reference value
The value of a parameter recommended by the Commission for use in a biokinetic
model in the absence of more specific information, i.e. the exact value used to
calculate the dose coefficients presented in ICRP reports. Reference values may be
specified to a greater degree of precision than that which would be chosen to reflect
the uncertainty with which an experimental value is known, in order to avoid theaccumulation of rounding errors in a calculation.
Reference level
In emergency or existing controllable exposure situations, this represents the level ofdose or risk, above which it is judged to be inappropriate to plan to allow exposures tooccur, and below which optimisation of protection should be implemented. The
chosen value for a reference level will depend upon the prevailing circumstances ofthe exposure under consideration. For medical exposures, the term “diagnostic
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reference levels” should be used to avoid confusion with the term “reference level”
used by the Commission for other exposures.
RegionA group of countries, usually defined by geographical proximity and/or culturalsimilarities, that agree to link together and pool resources for purposes of patient
dosimetry.
Regional diagnostic reference levels
DRLs set in a region, based on either a representative sample of healthcare facilities oron national DRL values.
Size-specific dose estimate (SSDE)A patient dose estimate for CT scans that takes into consideration corrections based on
the size of the patient, using linear dimensions measured on the patient or on patient
images. The American Association of Physicists in Medicine (AAPM) Report 204
bases SSDE values on the CTDlvol reported on CT scanners, but future modifications
may include SSDE correction factors based on other pertinent phantom measurements(AAPM, 2011).
Stochastic effects of radiation
Malignant disease and heritable effects for which the probability of an effect occurring,
but not its severity, is regarded as a function of dose without a threshold.
Tissue reaction
Injury in populations of cells, characterised by a threshold dose and an increase in theseverity of the reaction as the dose is increased further. Tissue reactions werepreviously called deterministic effects. In some cases, tissue reactions are modifiable
by post-irradiation procedures including healthcare and biological response modifiers.
Voxel phantom
See reference phantom.
REFERENCES

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AAPM, 2011. Size-specific dose estimates (SSDE) in pediatric and adult body CT
examinations. AAPM Report No. 204. American Association of Physicists in Medicine,College Park, MD.

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ICRU, 2005. Patient dosimetry for X rays used in medical imaging. ICRU Report 74. J. ICRU
5, 1–113.

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2

ICRP, 2007. The 2007 Recommendations of the International Commission on RadiologicalProtection. ICRP publication 103. Ann. ICRP 37(2–4).

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4

ICRU, 2012. Radiation dose and image-quality assessment in computed tomography. ICRU
Report 87. J. ICRU 1, 1–164.

5
6
7IEC, 2010. Report 60601 Medical electrical equipment - Part 2-43: Particular requirements
for the safety of X-ray equipment for interventional procedures, 2nd ed. International
Electrotechnical Commission, Geneva, Switzerland.

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NCRP, 2010. Radiation dose management for fluoroscopically guided interventional medical
procedures. NCRP Report No. 168. National Council on Radiation Protection andMeasurements, Bethesda, MD.

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NCRP, 2012. Reference levels and achievable doses in medical and dental imaging:recommendations for the United States. NCRP Report No. 172. National Council on
Radiation Protection and Measurements, Bethesda, MD.

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NEMA, 2010. Computed tomography dose check. NEMA Standards Publication XR 25-2010.
National Electrical Manufacturers Association, Rosslyn, Virginia.

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NRPB, 1999. Guidelines on patient dose to promote the optimisation of protection for
diagnostic medical exposures. Documents of the NRPB 10(1). National RadiologicalProtection Board, Chilton.

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INTRODUCTION

Diagnostic reference level (DRL) is the Commission’s term for a tool used for
optimisation of protection in the medical exposure of patients undergoingradiological imaging (including interventional procedures). DRLs are notintended for use in radiation therapy.
DRLs have been shown to be an effective tool for identification of examinations
using ionising radiation for which optimisation of protection should beundertaken.
All individuals who have a role in subjecting a patient to a medical exposure
should be familiar with DRLs as a tool for optimisation of protection.
Application of DRLs is not sufficient for optimisation of protection. The
diagnostic quality of the corresponding image(s) must also be evaluated.
The Commission considers use of the median of the distribution of a DRL
quantity observed in a survey of departments to be a useful additional tool for
improving optimisation and for identifying situations where investigation ofimage quality should be a priority.
The radiation metric quantity used for a DRL should be easily measured, such as
air kerma-area product (PKA) and entrance surface air kerma (Ka,e) for
diagnostic radiology, volume computed tomography (CT) dose index (CTDIvol)
and dose-length product (DLP) for CT, and administered activity for diagnostic
nuclear medicine.
Effective dose is not an appropriate quantity for use as a DRL. Effective dose is
not a measurable quantity and is not a good indicator of the amount of ionisingradiation used to perform a medical imaging task. Its use could introduce
extraneous factors not needed and not pertinent for the purpose of DRLs.
DRL values should not be used as dose limits. Dose limits do not apply to medical
exposures of patients.
Median values of distributions of DRL quantities obtained from groups ofpatients should be compared with DRL values. Values DRL quantities forindividual patients should not be compared with DRL values, because DRLs areintended for optimisation of protection for groups of patients, not individual
patients.

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1.1. Introduction3637(1) This report provides guidance for the practical use of diagnostic reference levels(DRLs) for specific imaging modalities, reviews methods for determining DRL values,

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provides advice on periodic revision of DRL values, and recommends DRL quantities for
specific imaging modalities. Compilations of DRL values are available from many sources(Hesse et al., 2005; Hart et al 2009, 2012; Miller et al., 2009, 2012b; NCRP, 2012; Padovani
et al., 2008; Samara et al., 2012; ICRP, 2007c; Foley et al., 2012; Lassmann et al., 2007;
Lassmann and Treves, 2014; Botros et al., 2009; Etard et al., 2012; ARSAC, 2014; Sánchez etal., 2014). This report discusses issues to be considered when setting and using DRLs as
opposed to providing lists of DRL values. It provides the Commission’s recommendations for
conducting surveys, determining DRL values, and applying the DRL process in clinicalfacilities.

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(2) This report uses symbols for DRL quantities defined by the International Commission
on Radiation Units and Measurements (ICRU). For the convenience of the reader, Table 2.2
provides the names, ICRU symbols, and common symbols for the quantities.

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1.2. Historical perspective on terminology

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(3) In its 1990 recommendations (ICRP, 1991), the Commission describes reference
levels (when used for applications other than medical exposures of patients), as values ofmeasured quantities above which some specified action or decision should be taken. These
include recording levels, above which a result should be recorded, lower values being
ignored; investigation levels, above which the cause or the implications of the result should be
examined; and intervention levels, above which some remedial action should be considered.
‘Diagnostic reference level’ was introduced in ICRP (1996) as the term for a form ofinvestigation level used to identify situations where optimisation of protection may berequired in the medical exposure of patients.

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(4) In its 2007 recommendations (ICRP, 2007a), the Commission uses the terms ‘dose
constraint’ in the context of planned exposure situations and ‘reference level’ for existing andemergency exposure situations. Thus, the term ‘reference level’ should not be used in thecontext of medical imaging. Although the medical exposure of patients is a planned situation,
the use of ‘dose constraints’ is not applicable (ICRP, 2007a).

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1.3. History

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(5) Wall and Shrimpton (1998) have reviewed the use of measurements of quantities
related to patient dose for optimisation of protection. Beginning in the 1950s, national surveys
of such quantities for diagnostic x-ray examinations were performed in the United States(U.S.) and the United Kingdom (U.K.) (Wall and Shrimpton, 1998). In the 1970s, theNationwide Evaluation of X-Ray Trends (NEXT) surveys began in the U.S. (FDA, 1984), andin the 1980s the National Radiation Protection Board [NRPB, now Public Health England(PHE)] surveys in the U.K. measured entrance surface exposure either free-in-air or incident
on the patient (Shrimpton et al., 1986). The results of these and similar surveys were the basis
for recommendations for radiographic technique and for levels of the quantities surveyed.
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These were first developed in the U.S. (CRCPD/CDRH, 1992; Jensen and Butler, 1978; Walland Shrimpton, 1998), then in the U.K. (NRPB/RCR, 1990), and subsequently in Europe (EC,
1996a, 1996b, 1999; Neofotistou et al., 2003; Padovani et al., 2008). These recommendations
were referred to variously as exposure guides, guideline doses, guidance levels (IAEA, 1996),
reference doses and, in Publication 73 (ICRP, 1996), as DRLs.

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(6) In 2001, the Commission published Supporting Guidance 2 (ICRP, 2001), which was
subsequently made available for free download from the Commission’s website(www.icrp.org) (ICRP, 2003). A summary of the Commission’s guidance on DRLs from
Publications 60 and 73, and Supporting Guidance 2 was included in Publication 105 (ICRP,
2007b).

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(7) In Europe, DRLs were formally introduced in Council Directive 97/43/EURATOM(EC, 1997), and Member States of the European Union were obligated to promote theestablishment and the use of DRLs as a strategy for optimisation. This obligation wasreiterated in the European Commission (EC, 2013), with a requirement for the establishment,
regular review and use of DRLs. The 2013 Council Directive also states that appropriate local
reviews are undertaken whenever DRLs are consistently exceeded, and that appropriate
corrective action is taken without undue delay. Several research programmes were launched
by EC, beginning in 1990, to collect data on patient doses and image quality, produce
guidance on image quality criteria for adult, paediatric radiology and CT and promote the useof DRLs (EC, 1996a,b, 1999a,b). During the years 1995-2005, additional programmes(SENTINEL, DIMOND) on digital and interventional radiology established initial DRL
values for newer imaging modalities.

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1.4. Effectiveness of DRLs

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(8) DRLs are an effective tool for optimisation of protection in the medical exposure ofpatients. The U.S. Breast Exposure: Nationwide Trends (BENT) mammographic quality
assurance (QA) programme was an early demonstration of the effectiveness of this approach(Jensen and Butler, 1978). An initial survey used phantoms to collect data on entrance
exposures from facilities in 19 states. On the basis of these data, trained surveyors visited
facilities with unnecessarily high or low values. These surveyors made recommendations for
improving aspects of the facilities’ imaging programmes. At one-year follow-up, there was asubstantial decrease in the mean entrance exposure and a decrease in the standard deviation of
the distribution of entrance exposures, with improved image quality.

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(9) In the U.K., where data have been collected approximately every 5 years since themid-1980s, DRLs determined from the results of the 2005 survey were 16% lower than thosein the 2000 survey, and approximately half of those in a mid-1980s survey (Hart et al., 2009,2012). The value of this tool was recognised in the EC’s 1997 Medical Exposure Directive(EC, 1997).

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1.5. Issues with the current use of DRLs

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(10)
There are several issues with the application of the DRL process in current
practice: misuse of DRLs for individual patients (or individual examinations) instead ofgroups of patients or a series of examinations, misuse of DRL values as a limit for individual
patients or individual examinations, using phantoms or inappropriate measures of radiation
output to set DRL values, establishing DRL values when there are differences in technology
among imaging systems and differences in necessary image quality for different clinicalindications for the same examination, and characterising image quality.

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(11)
With time, it has become evident that additional guidance is needed pertaining
to the proper clinical implementation of DRLs. Clarification is needed for definitions of someof the terms used in previous guidance, determination of the values for DRLs, the appropriate
interval for re-evaluating and updating these values, appropriate use of DRLs in clinicalpractice, methods for practical application of this tool, and application of the concept tocertain newer imaging technologies [e.g. dual-energy CT, positron emission tomography(PET)/CT, single-photon emission CT (SPECT)/CT, digital radiography, and tomosynthesis].

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1.5.1. DRLs are not intended for individual patients

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(12)
The appropriate and optimised dose for an individual depends on the patient’s
size and the purpose of the medical imaging task. Once protocols for “standard patients” areoptimised, the equipment’s automatic control mechanisms should be able to scale techniquefactors appropriately for smaller or larger patients. For nuclear medicine, the administeredactivity is weight-based.
(13)
In 2010, the National Electrical Manufacturers Association (NEMA) published
the Computed Tomography Dose Check standard (XR 25) (NEMA, 2010), and manufacturersof CT scanners began to implement this feature on their products. CT scanners that arecompliant with this standard will notify and alert the operator prior to starting a scan
whenever the estimated quantity [either volume CT dose index (CTDIvol) or dose-length
product (DLP)] is above one or more of two defined values. One of these, the "Notification
Value", is a value for a specific scan protocol. The CT Dose Check standard does not provide
specific numerical values for the Notification Value. While the American Association of
Physicists in Medicine (AAPM, 2011) has suggested numerical values for the Notification
Value, some facilities have elected to use DRLs instead. This use is not appropriate, as DRLs
are intended for optimisation of protection for groups of patients, not individual patients.

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1.5.2. DRLs are not dose limits

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(14)
The Commission’s principle of application of dose limits states that “the total
dose to any individual from regulated sources in planned exposure situations other than
medical exposure of patients should not exceed the appropriate limits recommended by theCommission” (ICRP, 2007a,b). It is important to note that this principle explicitly excludes
medical exposure of patients. Dose limits do not apply to medical exposures, defined by theCommission as “the exposure of persons as part of their diagnosis or treatment (or exposure
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of a patient’s embryo/fetus or breast-feeding infant) and their comforters and carers(caregivers) (other than occupational)” (ICRP, 2007b).
(15)
As the Commission has stated, “Provided that the medical exposures ofpatients have been properly justified and that the associated doses are commensurate with the
medical purpose, it is not appropriate to apply dose limits or dose constraints to the medical
exposure of patients, because such limits or constraints would often do more harm than good”(ICRP 2007b). It is therefore clear that DRL values are not intended as dose limits, and should
not be used as such.

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1.5.3. DRLs should be based on clinical practice

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(16)
For x-ray imaging, values for DRLs should in general be determined using dataon values of DRL quantities derived from patient examinations. Phantoms were often used in
the past. The Commission now recommends setting DRL values based on surveys of patient
examinations, because the numerical value of the DRL should be tied to defined clinical andtechnical requirements for the medical imaging task. The data gathered from patient
examinations provide a perspective on the distribution of these data that cannot be observed
using simple phantoms.
(17)
This report discusses when the use of phantoms or patient surveys is more
appropriate, and the limitations imposed by using phantoms instead of patient surveys. It
describes appropriate methods for determining DRL values, based on the particular imaging
modality and other concerns. It discusses setting DRL values when there is a limited sample
of data.
(18)
The Commission has previously recommended that the quantity used for a
DRL ‘should be easily measured, such as absorbed dose in air or tissue-equivalent material at
the surface of a simple standard phantom or representative patient for diagnostic radiology,
and administered activity for diagnostic nuclear medicine.” (ICRP, 2001). DRL quantities
should assess the amount of ionising radiation used to perform a medical imaging task. The
quantity or quantities selected are those that are readily available for each type of medical
imaging modality and medical imaging task.

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(19)
The quantity effective dose, used for other purposes in the ICRP system ofradiological protection, has been suggested for use as a DRL. It is not suitable for this purpose
because it does not assess the amount of ionising radiation used to perform a medical imaging
task and introduces extraneous factors not needed and not pertinent for the purpose of DRLs.
Also, effective dose is not readily available. Therefore, it should not be used as a quantity for
DRLs.

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1.5.4. Technology and clinical indication affect DRL values

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(20)
DRL values are dependent on the state of practice and the available technology
at a particular point in time. Technological advances may allow adequate image quality atvalues of the DRL quantity lower than an arbitrary percentile of the survey distribution. An
example is the introduction of iterative reconstruction for CT. These reconstruction
algorithms permit CT acquisitions at lower patient doses; in this case, DRL values based on
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CT performed with filtered back projection algorithms are not appropriate guides to indicate if
values of the DRL quantity are unusually high when iterative reconstruction is used.

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(21)
The Commission, in Publication 73, stated: “In principle, it might be possible
to choose a lower reference below which the doses would be too low to provide a sufficiently
good image quality. However, such reference levels are very difficult to set, because factors
other than dose also influence image quality” (ICRP, 1996). This difficulty is compounded
when, for example, some newer CT scanners use iterative reconstruction, but the DRL values
are based on surveys conducted primarily on older CT units. In this case, a value intended toindicate possible image quality issues for CT scanners that employ filtered back projection
would be inappropriate for CT scanners that employ iterative reconstruction.

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(22)
In some cases, different clinical indications for an examination may requiredifferent image qualities, and therefore different amounts of radiation. For example, a CT ofthe abdomen done to exclude renal calculi will require a lower value of the DRL quantity thana CT of the abdomen done to characterise a tumour. Therefore, the DRL values for these
indications should ideally be different. The same is true for certain screening examinations,such as low-dose CT for lung cancer screening.

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(23)
An area of particular concern is optimisation of follow-up examinations. Suchexamination protocols frequently do not require the same diagnostic information, and hence
the same amount of radiation to a patient, as is necessary in an initial examination intended toestablish a diagnosis. Follow-up examinations should be suitably optimised to their purpose,and will thereby result in both radiation and time saving.

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(24)
For interventional procedures, the amount of radiation applied to the patient
depends largely on the type of procedure and on procedure complexity. Procedure complexity
may vary for different clinical indications for the same procedure. For example, anephrostomy done for ureteric obstruction, where the renal collecting system is dilated,
requires less radiation to the patient than the same procedure done for a ureteric leak or foraccess for stone removal, a more complex and difficult procedure because the collecting
system is not dilated (Miller et al., 2003).

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1.5.5. Image quality must not be neglected

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(25)
“Image quality” can apply to a single image [e.g. for a posteroanterior (PA)chest radiograph], but the term may not be relevant with respect to single images when
multiple images are obtained and used for guidance or diagnosis, as in the case of fluoroscopy,
cineradiography, digital subtraction angiography and rotational angiography. In thesemodalities, a single image may demonstrate poor image quality, but evaluation of several
images, with the use of recursive filtering, may be adequate in terms of information content.
(26)
Criteria for characterising image quality have been defined and agreed upon
for certain specific adult and paediatric radiographs and for CT (EC, 1996a,b, 1999a), butsimilar criteria are lacking for other imaging modalities.

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8

(27)
In this report, the Commission emphasises the importance of the link between
the amount of radiation applied to the patient and image quality. Application of DRLs is not
sufficient for optimisation of protection. Image quality must be evaluated as well. For medical
exposures, the optimisation of radiological protection is best described as management of theradiation dose to the patient to be commensurate with the medical purpose (ICRP, 2007b). If
radiation dose is decreased to a level that results in image quality or diagnostic information
inadequate for the medical purpose, either by reducing dose or dose rate excessively or by
failing to obtain a sufficient number of images, optimisation has not been achieved.

9

1.6. Rationale for this report

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12
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14

(28)
The Commission’s most recently published guidance on DRLs is now nearly adecade old (ICRP, 2007b). There are a number of areas where the Commission believes that it
would be useful to provide additional guidance on the application of DRLs and thedevelopment of DRL values, clarification of previous recommendations, andrecommendations for newer technologies.

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21

(29)
Several terms used in earlier ICRP reports were not defined clearly. This reportclarifies and defines some of these terms, such as local, national, and regional DRLs. There
has been some confusion regarding the proper use of local DRLs in certain situations. In thisreport, the Commission provides recommendations on adapting local DRLs in facilities where
different types or levels of technology are used. Examples include newer CT scanners with
iterative dose reduction algorithms, interventional fluoroscopy systems with advanced dose
reduction software, and dental radiography with digital radiography detectors.

22
23
24

(30)
The majority of published DRL values are based on “standard” adults. In thisreport, the Commission provides recommendations for establishing DRL values and the use of
DRLs for paediatric patients (Chapter 6).

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32

(31)
This report discusses the use of DRLs in nuclear medicine, where DRLs havebeen assessed in a different way than in x-ray imaging (Chapter 5). In nuclear medicine,
administered radioactivity, absolute or weight adjusted, is used as the DRL quantity, and DRL
values have usually represented typical or optimised values rather than investigation levels.
Some imaging modalities use more than one method for irradiating the patient during a single
examination (e.g. PET/CT, SPECT/CT). In this report, the Commission provides
recommendations for applying the DRL process to optimisation of radiological protection forthese modalities.

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36

(32)
The Commission has not previously given advice on appropriate intervals forperiodic revision of DRL values. In Europe, the new directive on Basic Safety Standards
requires periodic revision of DRL values (EC, 2013). In this report, the Commission suggests
criteria for the timing of these revisions.

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(33)
DRL values are useful as investigation levels for optimisation of protection in
the medical exposure of patients, but they do not provide guidance on what is achievable with
optimum performance. In 1999, NRPB (1999) introduced a proposed new tool, ‘achievable
dose’ (AD), for this purpose. AD is a level of a DRL quantity “achievable by standard
techniques and technologies in widespread use, without compromising adequate image
quality” (NRPB, 1999). The NRPB introduced this concept to further improve efforts tomaximise the difference between benefit and risk in diagnostic procedures, withoutcompromising the clinical purpose of the examination. The NRPB proposed values for AD
that were based on the mean values observed for a selected sample of departments that met
EC recommendations on technique (NRPB, 1999).

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16

(34)
In 2012, the U.S. National Council on Radiation Protection and Measurements(NCRP) discussed the concept of AD further, and proposed that AD values be set at themedian value (the 50th percentile) of the distribution of a DRL quantity observed in a surveyof departments (NCRP, 2012). The Commission considers that this approach may be useful(i.e. use of the median of the distribution of a DRL quantity observed in a survey ofdepartments) as an additonal tool for improving optimisation.

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(35)
The use of the median of the distribution of a DRL quantity observed in asurvey of healthcare facilities may have an additional role. A certain degree of patient dose
reduction can be achieved without affecting image quality adversely. However, patient dosemust not be reduced so much that the images become non-diagnostic. The Commission (ICRP,
1996) has previously noted that, in principle, there could be an additional value specified thatwould serve as a simple test to identify situations where levels of patient dose are low andinvestigation of image quality should be the first priority (i.e. below which there might beinsufficient radiation dose to achieve a suitable medical image). The Commission has notpreviously specified such a value, either as an absolute value or as a percentile of the
distribution of data used to determine the DRL. The Commission now suggests that themedian value of the distribution of a DRL quantity observed in a survey of healthcare
facilities could be used for this purpose.

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(36)
The Commission has noted that, in principle, DRLs could be used for dosemanagement in interventional fluoroscopy with regard to stochastic effects (ICRP, 2007b).
DRLs are challenging to implement because of the very wide distribution in the amount ofradiation applied to patients, even for instances of the same procedure performed at the samefacility (ICRP, 2007b; Vañó and Gonzalez, 2001). Most published DRL values for theseprocedures are based on the 75th percentile of collected data for DRL quantities, in the same
fashion as DRL values for standardised radiographic examinations (Miller et al., 2009, 2012b;
Hart et al., 2009, 2012; Neofotistou et al., 2003; Padovani et al., 2008). The Commission has
previously suggested one possible approach, incorporating the complexity of theinterventional procedure, thereby adjusting the DRL value for different patient anatomy,
lesion characteristics, and disease severity. Complexity has been quantified for percutaneous
coronary interventions (PCI) (Bernardi et al., 2000). The International Atomic Energy Agency(IAEA) explored the feasibility of establishing DRL values for certain cardiology

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interventions using procedure complexity to normalise the amount of radiation applied (Balter
et al., 2008; IAEA, 2009).

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9

(37)
Assessing procedure complexity requires substantial clinical data, but thesedata are often not available. NCRP has recommended a different approach, applicable tostochastic effects, that uses data on appropriate DRL quantities from all cases of a specificinterventional procedure, rather than a sample of cases (Balter et al., 2011; Miller et al.,2012b; NCRP, 2010). In this report, the Commission discusses the advantages anddisadvantages of these different approaches to establishing DRL values for interventional
fluoroscopy, and provides recommendations on quantities (Chapter 4).

10
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12

(38)
DRLs are not applicable to management of the risk of tissue reactions (i.e.
radiation-induced skin injuries). The Commission has described other methods for managing
this risk (ICRP, 2013).

13

1.7. Target Audience

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(39)
DRLs are an effective tool for optimisation of protection in medical imaging.
In different countries, different individuals may be responsible for implementing optimisationof radiological protection in medical facilities. The individual with primary responsibility may
be a medical physicist, a physician, a radiographer, or an administrator. However, allindividuals who have a role in subjecting a patient to a medical exposure should be familiar
with DRLs as a tool for optimisation of protection.

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(40)
The target audience for this report is national, regional and local authorities
and the clinical community: professional societies, facilities where ionising radiation is used
for medical exposures, and responsible staff within these facilities. In particular, professional
medical societies of radiologists, cardiologists, and other practitioners who use radiation
should promote QA and quality improvement programmes that include evaluation of theamount of radiation applied using the DRL process.

26

1.8. Summary

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(41)
DRLs have proven to be a useful and valuable tool for optimisation ofradiological protection in medical exposures of patients. In this report, the Commission
refines its existing recommendations on using DRLs and determining DRL values andprovides additional recommendations that address areas of confusion and misuse. These
recommendations should help clarify the appropriate use of DRLs, and provide guidance on
the application of this tool to a wide variety of imaging modalities and clinical situations. Thisshould help prevent the inappropriate use of DRLs, such as treating a DRL value as a limit,
applying DRL values to individual patients, or using quantities that are not easily and directly
measureable.

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1.9. References

2
3
4
5

AAPM, 2011. AAPM recommendations regarding notification and alert values for CT
scanners: Guidelines for use of the NEMA XR 25 CT dose-check standard. American
Association of Physicists in Medicine, p. AAPM Dose Check Guidelines version 1.0
4/27/2011.

6
7
8
9
10
11
12

ARSAC (Administration of Radioactive Substances Advisory Committee). Notes for
Guidance on the Clinical Administration of Radiopharmaceuticals and Use of Sealed
Radioactive Sources, March 2006, Revised 2006, 2007 (twice), 2011 and 2014.
Balter, S., Miller, D.L., Vano, E., Ortiz Lopez, P., Bernardi, G., Cotelo, E., Faulkner, K.,
Nowotny, R., Padovani, R., Ramirez, A., 2008. A pilot study exploring the possibility of
establishing guidance levels in x-ray directed interventional procedures. Med. Phys. 35,
673–680.

13
14

Balter, S., Rosenstein, M., Miller, D.L., Schueler, B., Spelic, D., 2011. Patient radiation dose
audits for fluoroscopically guided interventional proedures. Med. Phys. 38, 1611–1618.

15
16
17
18

Bernardi, G., Padovani, R., Morocutti, G., Vaño, E., Malisan, M.R., Rinuncini, M., Spedicato,
L., Fioretti, P.M., 2000. Clinical and technical determinants of the complexity of
percutaneous transluminal coronary angioplasty procedures: analysis in relation toradiation exposure parameters. Catheter Cardiovasc. Interv. 51, 1–9; discussion 10.

19
20
21
22
23
24

Botros, G.M., Smart, R.C., Towson, J.E., 2009. Diagnostic reference activities for nuclear
medicine procedures in Australia and New Zealand derived from the 2008 survey. ANZ
Nucl. Med. 40, 2–11.
Center for Devices and Radiological Health, 1984. Nationwide Evaluation of X-Ray Trends(NEXT) eight years of data (1974-1981). U.S. Department of Health and Human Services,
Public Health Service, Food and Drug Administration.

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26

CRCPD/CDRH, 1992. Average Patient Exposure Guides—1992. CRCPD Pub. 92–4.
Conference of Radiation Control Program Directors, Frankfort, KY.

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28

DIMOND (Digital Imaging: measures for optimization of radiological information content
and dose). European Programme http://www.dimond3.org/ (accessed 12 March 2015)

29
30
31
32
33

Etard, C., Celier, D., Roch, P., Aubert, B., 2012. National survey of patient doses from wholebody FDG PET-CT examinations in France in 2011. Radiat. Prot. Dosim. 152, 334–338.
EC, 1996a. European guidelines on quality criteria for diagnostic radiographic images.
(Office for Official Publications of the European Communities, Luxembourg), Report
EUR 16260. CEC.

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35

EC, 1996b. Quality Criteria for Diagnostic Radiographic Images in Paediatrics, (Office for
Official Publications of the European Communities, Luxembourg), Report EUR 16261.

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3

EC, 1997. Council Directive 97/43/Euratom of 30 June 1997 on health protection ofindividuals against the dangers of ionising radiation in relation to medical exposure. Off J
Eur Commun L180, 22–27.

4
5EC, 1999a. European Guidelines on Quality Criteria for Computed Tomography. Report EUR
16262 EN. Official Publications of the European Communities (Luxembourg).

6
7
8
9

EC, 1999b. European Commission. Guidance on Diagnostic Reference Levels for Medical
Exposures.
Radiation
Protection
109(1999).
https://ec.europa.eu/energy/sites/ener/files/documents/109_en.pdf (accessed on 14 March
2015).

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12
13

EC, 2013. Council Directive 2013/59/Euratom of 5 December 2013 laying down basic safety
standards for protection against the dangers arising from exposure to ionising radiation,and repealing Directives 89/618/Euratom, 90/641/Euratom, 96/29/Euratom,
97/43/Euratom and 2003/122/Euratom. Off J Eur Commun L13, 1–73.

14
15

Foley, S.J., McEntee, M.F., Rainford, L.A., 2012. Establishment of CT diagnostic reference
levels in Ireland. Br J Radiol 85, 1390-1397.

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17

Hart, D., Hillier, M.C., Wall, B.F., 2009. National reference doses for common radiographic,
fluoroscopic and dental X-ray examinations in the UK. Br. J. Radiol. 82, 1–12.

18
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20

IAEA, 1996. International basic safety standards for protection against ionizing radiation andthe safety of radiation sources. Safety Series No. 115. International Atomic Energy
Agency, Vienna.

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22
23

IAEA, 2009. Establishing guidance levels in x ray guided medical interventional procedures:
A pilot study. Safety Reports Series No. 59. International Atomic Energy Agency,
Vienna.

24
25
26Hart, D., Hillier, M.C., Shrimpton, P.C., 2012. Doses to Patients from Radiographic andFluoroscopic X-ray Imaging Procedures in the UK – 2010 Review Report HPA-CRCE034 (HPA: Chilton).

27
28

ICRP, 1991. 1990 Recommendations of the International Commission on RadiologicalProtection. Publication 60. Ann. ICRP 21(1–3).

29
30

ICRP, 1996. Radiological protection and safety in medicine. ICRP Publication 73. Ann. ICRP
26(2).

31
32

ICRP, 2001. Radiation and your patient: a guide for medical practitioners. Supporting
Guidance 2. Ann. ICRP 31(4).

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34

ICRP, 2003. Diagnostic reference levels in medical imaging: review and additional advice.
ICRP online educational reference.
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2

ICRP, 2007a. The 2007 Recommendations of the International Commission on RadiologicalProtection. ICRP Publication 103. Ann. ICRP 37(2–4).

3

ICRP, 2007b. Radiation protection in medicine. ICRP Publication 105. Ann. ICRP 37(6).

4
5

ICRP, 2007c. Managing patient dose in multi-detector computed tomography (MDCT). ICRP
Publication 102. Ann. ICRP 37(1).

6

ICRP, 2013. Radiological protection in cardiology. ICRP Publication 120. Ann. ICRP 42(1).

78Jensen, J.E., Butler, P.F., 1978. Breast exposure: nationwide trends; a mammographic quality
assurance program--results to date. Radiol. Technol. 50, 251–257.

9
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11

Lassmann, M., Biassoni, L., Monsieurs, M., Franzius, C., Jacobs, F. for the European
Association of Nuclear Medicine (EANM) Dosimetry and Paediatrics Committees, 2007.
The new EANM paediatric dosage card. Eur. J. Nucl. Med. Mol. Imaging 34, 796–798.

12
13
14
15

Lassmann, M., Treves, S.T. for the EANM/SNMMI Paediatric Dosage Harmonization
Working Group, 2014. Paediatric radiopharmaceutical administration: harmonization of
the 2007 EANM paediatric dosage card (version 1.5.2008) and the 2010 North American
consensus guidelines. Eur. J. Nucl. Med. Mol. Imaging 41, 1036–1041.

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Miller, D.L., Balter, S., Cole, P.E., Lu, H.T., Schueler, B.A., Geisinger, M., Berenstein, A.,
Albert, R., Georgia, J.D., Noonan, P.T., St George, J., Cardella, J.F., Russell, E., Malisch,T., Vogelzang, R.L., Miller, G., Anderson, J., 2003. Radiation doses in interventional
radiology procedures: The RAD-IR study Part I. Overall measures of dose. J. Vasc. Interv.
Radiol. 14, 711–727.

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Miller, D.L., Hilohi, C.M., Spelic, D.C., 2012. Patient radiation doses in interventional
cardiology in the U.S.: Advisory data sets and possible initial values for U.S. reference
levels. Med. Phys. 39, 6276–6286.

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Miller, D.L., Kwon, D., Bonavia, G.H., 2009. Reference levels for patient radiation doses ininterventional radiology: proposed initial values for U.S. practice. Radiology 253, 753–
764.

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NCRP, 2010. Radiation dose management for fluoroscopically guided interventional medical
procedures. NCRP Report No. 168. National Council on Radiation Protection andMeasurements, Bethesda, MD.

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32

NCRP, 2012. Reference levels and achievable doses in medical and dental imaging:recommendations for the United States. NCRP Report No. 172. National Council on
Radiation Protection and Measurements, Bethesda, MD.

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34

NEMA, 2010. Computed tomography dose check. NEMA Standards Publication XR 25-2010.
National Electrical Manufacturers Association, Rosslyn, Virginia.
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3

Neofotistou, V., Vano, E., Padovani, R., Kotre, J., Dowling, A., Toivonen, M., Kottou, S.,
Tsapaki, V., Willis, S., Bernardi, G., Faulkner, K., 2003. Preliminary reference levels ininterventional cardiology. Eur. Radiol. 13, 2259–2263.

4
5
6

NRPB, 1999. Guidelines on patient dose to promote the optimisation of protection for
diagnostic medical exposures. Documents of the NRPB 10(1). National RadiologicalProtection Board, Chilton.

7
8

NRPB/RCR, 1990. Patient dose reduction in diagnostic radiology. Documents of the NRPB
1(3). HMSO, London.

9
10
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12

Padovani, R., Vano, E., Trianni, A., Bokou, C., Bosmans, H., Bor, D., Jankowski, J., Torbica,P., Kepler, K., Dowling, A., Milu, C., Tsapaki, V., Salat, D., Vassileva, J., Faulkner, K.,
2008. Reference levels at European level for cardiac interventional procedures. Radiat.
Prot. Dosim. 129, 104–107.

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Samara, E.T., Aroua, A., De, P.R., Stauffer, J.C., Schmidt, S., Trueb, P.R., Stuessi, A., Treier,R., Bochud, F., Verdun, F.R., 2012. An audit of diagnostic reference levels ininterventional cardiology and radiology: are there differences between academic and nonacademic centres? Radiat. Prot. Dosim. 148, 74–82.

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19

Sánchez, R.M., Vano, E., Fernández, J.M., Escaned, J., Goicolea, J., Pifarré, X.; DOCCACI
Group, 2014. Initial results from a national follow-up program to monitor radiation doses
for patients in interventional cardiology. Rev. Esp. Cardiol. (Engl Ed). 67, 63–65.

20
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23

SENTINEL European Programme. (Safety and Efficacy for New Techniques and Imaging
Using New Equipment to Support European Legislation: Supporting Digital Medicine)
http://ec.europa.eu/research/energy/print.cfm?file=/comm/research/energy/fi/fi_cpa/rpr/ar
ticle_3854_en.htm (accessed 12 March 2015).

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26

Shrimpton, P.C., Wall, B.F., Jones, D.G., Fisher, E.S., Hillier, M.C., Kendall, G.M., Harrison,
R.M., 1986. A national survey of doses to patients undergoing a selection of routine x-ray
examinations in English hospitals. NRPB-R200. HMSO, London.

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Vañó, E., Gonzalez, L., 2001. Approaches to establishing reference levels in interventional
radiology. Radiat. Prot. Dosim. 94, 109–112.

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Wall, B.F., Shrimpton, P.C., 1998. The historical development of reference doses indiagnostic radiology. Radiat. Prot. Dosim. 80, 15–19.

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2.

CONSIDERATIONS IN CONDUCTING SURVEYS TO ESTABLISH DRLS

3
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•

Where appropriate or required, national or state legislation should clearly
identify organisations having responsibility for different components of the tasks
of collating data on DRL quantities and setting DRLs.
The first step in setting DRLs is to identify the examinations/procedures forwhich DRLs should be established. They should represent the common
examinations performed in the region, with priority given to those that are
performed with the highest frequency or that result in the highest patientradiation dose. They should also be ones for which assessment of DRL quantities
is practicable.
The primary variables that are recorded should be quantities that can be readily
assessed, preferably from a direct measurement for the examination (e.g. PKA,
Ka,e, DLP, CTDIvol, administered activity), and that indicate the amount ofradiation or administered activity applied.
The survey will normally comprise larger or medium-size facilities that have asufficient workload to ensure that data for a representative selection of patientscan be obtained. A survey for a particular examination in a facility would
normally involve the collection of data on the DRL quantity for at least 20
patients, preferably 30 for diagnostic fluoroscopy examinations and 50 patientsfor mammography. The sample should also cover the range of healthcare
providers.
A survey of a random selection of a small proportion of all the imaging facilities
can provide a good starting point. Results from 20-30 facilities are likely to be
sufficient in the first instance. In a small country with fewer than 50 facilities, asurvey of 30% to 50% of them may suffice.
Hospital and Radiology Information Systems can provide data for large numbersof patients. Wherever possible, utilisation of electronic transfer of these data is
recommended.
There should be some standardisation of weight for patients included in surveys.
Calibrations of all dosimeters, PKA meters, etc., used for patient dosimetry shouldbe performed regularly and should be traceable to a primary or secondary
standard laboratory. The accuracy of DRL quantity data produced by andtransferred from x-ray systems should be periodically verified by a medical
physicist.
The Commission now recommends that the median value (not the mean value)
for the DRL quantity from each of the facilities in the survey should be used.
National DRLs should be set as the 75th percentile of median values obtained in asample of representative centres.

•

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When national DRL values exist for many or most countries within a region,
regional DRL values may be determined by using the median value of theavailable national DRL values.
National and regional DRLs should be revised at regular intervals (3-5 years) or
when substantial changes in technology, new imaging protocols or postprocessing of images become available.
Assessment of clinical image quality should be performed as part of the
optimisation process. Objective measures should be used where these areavailable.
The median (the 50th percentile) of the distribution used to set the national DRL
may also be used as an additonal tool for optimisation.

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2.1. Introduction

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(42)
This chapter deals with the development of a DRL programme andestablishment of DRL values for diagnostic procedures – diagnostic radiography andfluoroscopy, mammography, dentistry and nuclear medicine. Digital radiography, CT, nuclear
medicine, and multimodality procedures are also dealt with in Chapter 5, and specificconsiderations for paediatric examiantions are dealt with in Chapter 6, but general principles
that apply to all diagnostic examinations are discussed here. DRLs were originally developedwith the underlying assumption that they are for a “standard” examination, where the value of
the DRL quantity for a specific examination performed on a specific radiographic unit willvary only as function of body part thickness (or some other measure of body mass).
Interventional procedures are by their nature non-standard and are dealt with separately in
Chapter 4.

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(43)
DRLs are a form of investigation level used to aid in optimisation of protectionin the medical exposure of patients for diagnostic and interventional procedures. A DRL isdefined for types of equipment for typical examinations of groups of standard-sized patientsor, in certain specific circumstances, a standard phantom. It is derived from an arbitrary
threshold in a distribution and is not a scientific definition. DRLs are supplements to aprofessional judgement, and do not provide a dividing line between good and bad medicine.

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(44)
DRLs utilise ‘DRL quantities’ – commonly and easily measured or determined
quantities or metrics (e.g. Ka,e, Ka,i, CTDIvol, DLP, PKA, Ka,r, DG) that assess the amount ofionising radiation used to perform a medical imaging task. These quantities indicate theamount of radiation or administered activity applied, and not the actual absorbed doses intissues and organs of the patient.

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(45)
The quantities selected are those that are readily available for each type of
medical imaging modality and medical imaging task. DRLs are utilised to evaluate whether,in routine conditions, the median value of a DRL quantity obtained for a representative groupof standard-sized patients from a specified procedure is unusually high or low for thatprocedure.
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(46)
DRLs should be representative of procedures performed in the local area,
country or region where they are applied. In some countries, hospitals or health authorities
may set their own local DRLs. These will ideally be based on national values, but can be
adjusted to apply to local practices to encourage further optimisation. They can also be used
to set lower values for new technologies that allow lower dose levels to be achieved. Where
no national or regional DRLs are available, DRLs can be set based on local dosimetry orpractice data.

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(47)
A ‘DRL value’ is a selected numerical value of a DRL quantity, set at the 75th
percentile of the medians of DRL quantity distributions observed at healthcare facilities in anation or region. DRL values are not static. As optimisation continues or hardware andsoftware improve, DRLs should be updated on a regular basis. When new imaging techniques
are introduced, an effort should be made to measure appropriate DRL quantities and set DRL
values as soon as is practicable. Software tools for collection and management of dose-related
data may simplify the process of establishing and updating DRL values.

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(48)
In nuclear medicine, the DRL represents what is regarded as the acceptablelevel of radioactivity to administer for an examination of an average patient. The practices
involved in the use of DRLs in nuclear medicine are different from those in diagnostic
radiology, although they serve a similar purpose, to assist in establishing agreed requirements
for good practice. DRLs for nuclear medicine and hybrid imaging procedures are discussed in
more detail in Chapter 5.

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(49)
Median values of DRL quantities for diagnostic procedures for a specific x-ray
room or for a radiology department or other section of a healthcare facility can be comparedwith DRL values to identify whether the median values in the room, department or facility arehigher or lower than might be anticipated. Comparison of data from local practice to the DRL
value is the first step in the optimisation of protection, and can indicate whether aninvestigation of practices should be performed.

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(50)
If the median value of a DRL quantity for a particular type of examination in aparticular healthcare facility exceeds the relevant DRL value (or is less than some specified
percentile), an internal investigation should be carried out by the facility as soon aspracticable. The investigation should either identify ways of improving practice by using theappropriate amount of radiation, or clinically justify the use of such higher (or lower) amountsof radiation.

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38

(51)
Compliance with DRL values does not necessarily indicate that image quality
is appropriate and that the examination is performed with an optimal amount of radiation.
Image quality must be assessed as part of the optimisation process. Comparison of the medianvalue of the DRL quantity at the facility to the median value of the distribution used todetermine the DRL value may also help in the optimisation by indicating when attention
should be directed first to an evaluation of image quality (Section 2.6.2).

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1

2.2. Approach to setting DRL values

2
3
4
5
6

(52)
The first and perhaps the most difficult step is setting the DRL value. Thisshould be tied to defined clinical and technical requirements for the medical imaging task. A
selected numerical value for one situation may not be applicable to different clinical andtechnical requirements, even if the same area of the body is being imaged. The requirements
can be general or specific.

7
8
9
10
11
12

(53)
In general, and for the majority of types of examinations, DRL values should
be based on measurements made in surveys of patient examinations. It is difficult todetermine what value of a DRL quantity is just low enough and what image quality is justgood enough to provide the required diagnostic information. Pooling of data from surveys
provides results from which it is possible to decide that the majority of radiologists agree thata particular value of the DRL quantity produces an image that is adequate for diagnosis.

13
14
15
16
17
18
19
20

(54)
Phantoms can be useful for assessing general radiographic exposures obtainedwith automatic exposure control (AEC) for comparison of the performance of different x-ray
units (Conway et al., 1992) or for checking the performance of mammography units, butsetting DRL values by using phantom-based surveys is not appropriate. Phantom data do notnecessarily reflect the clinical and technical requirements for the medical imaging task. Also,
they do not incorporate operator performance and may not incorporate protocol use in thesame way as patient data obtained from surveys. If phantoms are used, their use should be justthe first step in setting up a more complete system based on patient measurements.

21
22
23
24
25
26

(55)
The one exception to using data from patient surveys to set DRL values isdental radiography equipment (Chapter 3). Since the same standard exposure settings, linked
to the teeth being imaged, are used for the majority of adults, a measurement of output withthe appropriate settings can be considered as the median incident air kerma or patient dose foreach dental unit. DRLs can then be set based on the distribution of the measurements of
output for different dental units.

27
28

(56)
A summary of approaches recommended for different types of diagnostic
examination is given in Table 2.1.

29

Table 2.1. Examination selection.
Examination

DRL recommended

Method of assessment

Mammography

Yes

Patient survey and phantom
measurements

Dental radiology

Yes

Output measurement on standard
settings

CT

Yes

Patient survey

Radiography of the trunk

Yes

Patient survey preferred

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DRAFT REPORT FOR CONSULTATION: DO NOT REFERENCE

Skull radiography

Yes

Patient survey

Paediatric radiology

Yes

Patient survey

Extremity radiography

Yes (lower priority)

Patient survey

Mobile radiography

Yes (lower priority)

Patient survey

Neonatal radiography

Yes

Patient survey

Paediatric mobile radiography

Yes (for dedicatedchildren’s hospitals)

Patient survey

Barium studies

Yes

Patient survey

Interventional radiology andcardiology

Yes

Patient survey

Other fluoroscopy

Possibly, depending
on level of use

Patient survey

Nuclear medicine - adult

Yes

Based on administered activity

Nuclear medicine - paediatric

Yes

Based on administered activity withadjustments for the size or weight ofthe child

Bone densitometryYes (lower priority)

Patient survey

1
2
3
4
5
6

(57)
National and regional DRLs need to be based on valid comparisons. DRLs
should be created for specific examinations. Comparisons must be like-for-like if they are to
be meaningful. Moreover, DRLs should be derived from a group of facilities that is both large
enough and sufficiently diverse to represent the range of practices within the country or
region for the particular examination or procedure.

7
8
9

(58)
Since practices and equipment will vary from one country or region to another,
it is important that national and regional DRLs are representative of procedures performed in
the country or region where they are applied.

10
11
12
13
14

(59)
The best source for a DRL value is patient-based data for the country or regionin which it will be used. Methods through which such DRLs can be derived are described insubsequent sections in this chapter. DRL values obtained from other sources can also provide
useful data. These data can be used in the first instance for establishment of initial DRL
values and for comparisons.

15
16

(60)
DRL values published by other national or international organisations can bereferred to when setting national DRLs. Examples are available from a number of sources,
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DRAFT REPORT FOR CONSULTATION: DO NOT REFERENCE

1
2
3
4
5
6

including EC (1996a,b, 1999a,b, 2014), the HPA (2012) and NCRP (2012). However, these
DRLs will not necessarily be appropriate for many countries and states, since diagnostic
procedures may be defined differently (e.g. “abdomen CT” may be a CT of the abdomen or aCT of the abdomen and pelvis), the available hardware, software and expertise may vary(different radiological devices, technologies or procedures), and population groups, including
typical pathologies, the purpose of the examination, and patient weight distribution may vary.

7

2.3. Survey considerations

8

2.3.1. Responsibility for conducting surveys and establishing DRLs

9
10
11

(61)
National DRLs should be appropriate for the range and numbers of medical
procedures undertaken using ionising radiation in that country. Such DRLs provide targets
that all facilities are encouraged to meet.

12
13
14
15
16

(62)
Regional DRLs relate to groups of countries that are thought to use similar
practices, where a pooling of resources can reduce the workload and provide DRLs based on amore substantial data set. Establishment of regional DRL values should be accomplished in amanner consistent with the concepts expressed in this report, and the methodology should be
agreed upon among the competent authorities of all participating countries.

17
18
19
20

(63)
The establishment of national or regional DRLs requires surveys of patients
across a whole country or region, and should be co-ordinated by a national or regionalorganisation, with support from national governments. This will require the provision ofnecessary resources.

21
22
23
24
25

(64)
Regulatory requirements for setting DRL values, the application of DRLs, andthe optimisation of protection for medical exposures are recommended in order to promote
good practice. There are wide variations in the approach to management of patient dose indifferent parts of the world (Martin et al., 2013). Thus, there is a need for flexibility in themanner in which DRLs are established and optimisation programmes are implemented.

26
27
28
29

(65)
National or state legislation should clearly identify organisations having
responsibility for different components of the task. Collation of patient data and setting of
national or regional DRLs needs to be done at a national or regional level. However, manydifferent groups may carry out the actual measurements and collection of patient data.

30
31
32
33
34

(66)
Organisations that undertake surveys of patients may be government
institutions, health authorities, scientific or professional societies, academic institutions,
hospitals, radiology facilities or clinics. These surveys could be accomplished by medical
physicists or other staff with responsibilities in radiological protection, either employed by theorganisation or through private contracts, or by training of in-house radiographers.

35
36

(67)
Geographical areas within a country (e.g. states, provinces, counties) may havethe infrastructure and necessary collaboration between professionals to develop their own

37

DRAFT REPORT FOR CONSULTATION: DO NOT REFERENCE

1
2
3

DRL values where there is a perceived need. Such collaborative groups may be able toperform surveys more quickly once an infrastructure is in place and so react more quickly toaddress perceived changes in practice.

4
5
6
7
8
9
10
11
12

(68)
Local DRL values set by a group of radiology departments or even a single
facility can also play a role. By their nature, national and regional DRLs can take longer toassess, review and revise. Larger hospitals or groups of hospitals may already have invested
the effort to achieve a higher level of optimisation. Where this is the case, the group could
choose to set its own, lower, local DRL value based on more regular surveys of local practice.
A local DRL value will normally be lower than the national DRL value, unless it is designed
for a different clinical task or on a group of patients with a more demanding clinical condition.
The Institute of Physics and Engineering in Medicine (IPEM, 2004) contains a comprehensive
report on the implementation and use of local DRLs.

13
14
15
16
17

(69)
Local DRL values can also be established for newer technologies that enable
lower dose levels to be used in achieving a similar level of image quality or diagnostic
information. Examples of this are where iterative reconstruction techniques are used for CT
images instead of filtered back projection, or where more sensitive digital radiography
detectors (DR) replace computed radiography (CR) for general radiography or dental imaging.

18
19
20

(70)
Local DRLs can be of value where a facility performs large numbers ofspecialised examinations for which there is no national DRL. This could apply to a major
centre for a specific type of specialist treatment.

21
22
23
24

(71)
Where local DRL values are set, the facility may need to base these mainly on
its own practice if there are no national DRL values available. However, countries throughout
the world are now setting DRL values for different imaging tasks, and reference to values
used by other centres can provide a useful guide as to whether further optimisation is required.

25
26
27
28

(72)
In some countries, government departments or universities have undertaken
surveys in the past (Martin et al., 2013). The experience of established groups may be utilised,
but will require co-ordination and supervision in order to ensure accuracy and consistency ofdata collection, and uniform coverage of x-ray facilities.

29
30
31
32
33
34

(73)
Since an understanding of the imaging and radiation performance of theequipment is required for optimisation, periodic constancy testing should be carried out, andthe results should be evaluated by a qualified medical physicist. This may be mandated
through regulations. In the U.K., where DRLs have been employed successfully in the
optimisation process for many years, medical physicists oversee both performance tests on xray equipment and patient surveys.

35
36
37
38
39

(74)
In order to ensure that the setting of DRL values leads to optimisation ofprotection for medical exposures, both staff who operate the equipment and carry out theprocedures and staff who perform constancy testing need to be made aware of the results andneed to work together in the optimisation process. Close collaboration between the different
groups is essential if optimisation is to be fully realised.
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1

2.3.2. Facilities

2
3
4
5
6
7
8
9
10

(75)
The first step in setting DRLs is to carry out surveys of patient examinations
across the geographical area to which the DRL will apply. In a developed country withhundreds of healthcare facilities, a survey of them all would be a mammoth task. A random
selection of a small proportion of all the healthcare facilities as a sample can provide a goodstarting point. Thus, results from 20-30 facilities are likely to be sufficient in the first instance,
if a sufficient number of patients from each facility are included (Section 2.3.3). In a small
country with fewer than 50 facilities, an initial survey of 30% to 50% of the facilities may
suffice. In subsequent surveys, as the data collection infrastructure improves, the number offacilities included can be extended to give more representative coverage.

11
12
13
14

(76)
Selection of a representative sample of facilities is normally sufficient, asshown by experience in the U.K. The first set of guideline doses (i.e. DRL values) in the U.K.
was derived from mean values for particular examinations for each x-ray room in 20 hospitals
selected at random. Patients included in the study had weights within a restricted range.

15
16
17
18

(77)
The facilities included should have a sufficient workload to ensure that data for
a representative selection of patients can be obtained. They would normally be larger or
medium size hospitals, since the patient cohort in a small hospital or other healthcare facility
may be insufficient to allow a reasonable sample to be obtained in a realistic time frame.

19
20
21
22
23
24
25

(78)
The sample should also cover a representative selection of healthcare providers.
In a majority of countries, these may be both public and private, hospital and freestanding,and priorities for optimisation may be different in different facilities. Smaller facilities withlimited numbers of radiographers may employ unusual practices that do not reflect those usedwidely across the country. Although it is important to be aware of these practices, they should
be identified in the next round of patient surveys when comparisons are made with the DRL
values that have already been established.

26
27
28
29
30

(79)
The first survey of healthcare facilities in a geographical area will need to beorganised centrally. Where there are only a few diagnostic radiology medical physicists, a
medical physicist may need to visit each facility to carry out quality control (QC) testing,including measurement of x-ray equipment output, and to make arrangements for datacollection.

31
32
33
34
35
36
37
38
39

(80)
The U.K. first introduced guideline doses (precursors of DRLs) in 1989
(Shrimpton et al., 1989) and has developed the application of the concept over the last 25
years. National DRL values have been set in the U.K. at the arbitrary level of the third quartileof the mean (not median) values of DRL quantities measured in large-scale hospital surveys.
Thus, by definition, one quarter of the mean values for each examination in the survey
exceeded the proposed DRL. However, a few outlier data points can affect a hospital’s meanvalue substantially. Therefore, the Commission now recommends use of the median value ofthe local data. Also, local data should be obtained from a representative sample of typicalpatients.

39

DRAFT REPORT FOR CONSULTATION: DO NOT REFERENCE

1
2
3
4

(81)
The initial establishment of national or regional DRL values is the first step ina continuing process. Thereafter, surveys will need to be repeated periodically to evaluatechanges. Once initial DRL values have been set, subsequent surveys may take the form ofcollation of measurements made by local medical physicists or radiology staff.

5
6
7
8
9
10
11
12
13

(82)
Once a DRL framework has been put in place, a suitable interval between
national or regional data collection surveys may be 3 years to as much as 5 years (the interval
used in the U.K.), but this will depend on the examination levels, the degree of variability ofthe survey results, the introduction of new technology or imaging post-processing software,and the availability of staff to undertake the analysis. In one Spanish university hospital, Vaño
et al. (2007) used an automated collection system with a database of 204,660 data points toevaluate changes in patient radiation levels during the transition from film-screen to digitalradiography. They demonstrated the importance of frequent patient audits when imaging
technology changes.

14
15
16
17
18

(83)
Where there has been a drive to encourage healthcare facilities throughout ageographical area to perform their own patient surveys, then collection of further data on atime scale of a few years may be achievable. Once optimisation is started, the amount ofradiation administered to patients is likely to decrease, so it is important to review the data
and update DRL values to maintain the momentum of improvement.

19

2.3.3. Patients

20
21
22
23
24
25
26
27
28

(84)
The majority of the discussion in this chapter is devoted to the collection ofdata on DRL quantities for individual patients, and the determination of DRL values based onthese data. However, there are some limited circumstances in which the performance ofequipment with regard to the amount of radiation used can be assessed by simple
measurements or by using phantoms. These include dental radiography, mammography, and,to some extent, radiography and diagnostic fluoroscopy. Such measurements should be
regarded as useful adjuncts performed during QC assessments, but in general should not
replace surveys of patients. Use of phantoms is discussed further in Chapter 3 in thesubsection for each imaging modality.

29
30
31
32
33
34
35
36
37
38
39
40

(85)
Since attenuation of the x-ray beam depends on the amount of tissue the beam
has to penetrate, it is important to have some standardisation of patient size if the number ofpatients for whom data are collected is limited. Standardisation of patient size is usuallyaccomplished through weight restriction. For adults, this is achieved typically by using datafrom patients with weights within a certain range, e.g. a range of 50 kg to 90 kg can be used toachieve a 70 kg mean. A mean weight of 70 kg ± 5 kg was chosen as a reference weight in the
U.K., as representing the average in the U.K. at the time (IPSM, 1992). This mean weight is
not necessarily appropriate for other countries with different weight distributions in their
population, and with current trends in population weight, it may not be appropriate for the
U.K. in the future. The mean weight chosen should be close to the average weight in the
population being considered. A mean weight of 70 kg ± 10 kg may be appropriate for somecountries.

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DRAFT REPORT FOR CONSULTATION: DO NOT REFERENCE

1
2
3
4
5
6
7

(86)
Where automated methods of recording values of DRL quantities are available,
it may be possible to collect data for large numbers of patients (>100) at each facility (Goenka
et al., 2015; MacGregor et al., 2015). Where this is possible, restrictions on weight can beremoved. Results rely on the accuracy of data entry, and may not include patient weight.
Exclusion of the highest and lowest 5% of the data will eliminate outliers and data with grosserrors from the analysis. Specific considerations for development of DRLs for paediatricpatients are discussed in Chapter 6.

8
9
10

(87)
Where collection of data is only possible for smaller numbers of patients, theuncertainty in the median or mean may be large. The interquartile range serves as an indicatorof dispersion of the data (see Section 7.1).

11
12
13
14
15
16
17
18
19

(88)
A survey of the DRL quantity for a particular examination in a hospital would
normally involve the collection of data for at least 20 patients for radiographic examinations(IPSM, 1992). However, data for more patients will be required when there are a greater
variation and wide range of results. This is especially true for fluoroscopy, where differencesin patients’ disease states and operator technique contribute to the variation. A group of atleast 30 patients within the agreed weight range is preferable for diagnostic fluoroscopy
procedures (IPSM, 1992). Even larger numbers of patients may be needed for interventional
procedures (Chapter 4). For mammography, 50 patient measurements are recommended
because of variation in breast size.

20

2.3.4. Examinations and DRL quantities

21
22
23
24
25
26
27
28

(89)
The first priority in selecting examinations and imaging procedures for which
DRL values should be set is to include those common examinations performed in the region,
with priority given to those that are performed with the highest frequency or that result in thehighest patient radiation dose. These should also be examinations for which dose assessment
is practicable and should encompass all groups of operators. The choice of examinations will
also be influenced by the expertise of the personnel available to oversee the survey and toadvise about subsequent optimisation required. Table 2.1 categorises certain examinations.
The aim should be to eventually provide DRL values for all procedures commonly performed.

29
30
31
32
33
34

(90)
In the first instance, it may be decided that radiography should be surveyed, as
it is the most widely used technique, measurement of DRL quantities is relatively simple, andoptimisation of protection is relatively straightforward. Alternatively, CT may be chosen, as it
is frequently performed and results in relatively high patient radiation doses. For CT, it isparticularly important that appropriately trained medical physicists are involved to provide
advice on the optimisation of protection.

35
36
37
38

(91)
Setting DRL values for multiple quantities rather than a single quantity
provides a guide to good practice and can simplify the investigation of practices at a facility
by drawing attention to a specific area for improvement. This can form a useful part of an
optimisation programme to encourage improvement in skills and practices of individuals.

39

Table 2.2. ICRU symbols for DRL quantities.
41

DRAFT REPORT FOR CONSULTATION: DO NOT REFERENCEICRU Symbol*

Meaning

Other Common Symbol

CTDIvol

Volume Computed Tomography Dose
Index

DLP

Dose Length Product

Ka,iIncident air kerma

IAK

Ka,e

Entrance-surface air kerma

ESAK, ESD

Ka,r

Incident air kerma at the Patient Entrance
Reference Point

CAK

DG

Mean glandular dose

MGD, AGD

1

PKA
Air kerma-area product
KAP, DAP*This report uses ICRU symbols. Other common symbols are shown for the convenience of the reader.

2
3
4
5
6
7
8
9
10
11
12
13
14
15

(92)
Data collected for patient surveys should, when feasible, include the equipment
manufacturer and model, the examination name, patient weight, and PKA and other DRL
quantities (e.g. CTDIvol, DLP, Ka,e, Ka,r) if appropriate and available for the types of
examination being surveyed (for the convenience of the reader, Table 2.2 lists the symbols for
DRL quantities and their meaning). The quantities recommended by the Commission are
given in Table 2.3. For fluoroscopy and CT, all of the quantities listed should be recorded ifthey are available. The quantities chosen should be easily measured, such as absorbed dose in
air or tissue equivalent material at the surface of a representative patient (or, for certain
specific examinations, a representative phantom) for diagnostic radiology, and administeredactivity for diagnostic nuclear medicine. The DRL quantity selected (e.g. CTDIvol, DLP,
administered activity) should allow assessment of the amount of ionising radiation used toperform the medical imaging task, and is not (with the exception of DG	
   for mammography)
the absorbed dose in a tissue or organ of the body.

16
17

Table 2.3. Quantities suitable for setting DRLs.
Equipment

Recommended quantity

Recommended unit

Radiography

Ka,e

mGy

PKA

mGy⋅cm2

Mammography, breast
tomosynthesis

Ka,e Ka,i or DG*

mGy

Dental intra-oral

Ka,i

mGy

Dental panoramic

PKA (or dose width
product)mGy⋅cm2 (mGy⋅cm)

Diagnostic fluoroscopy,
interventional fluoroscopy

PKA

Gy⋅cm242

DRAFT REPORT FOR CONSULTATION: DO NOT REFERENCE

CT, interventional CT
Cone-beam CT (depending on
availability of the quantity)

Nuclear medicine

Ka,r

Gy

Fluoroscopy time

seconds

Number of images in cineor digital subtraction
angiography (DSA) runs

numberCTDIvolmGy

DLP

mGy⋅cm

Ka,r

mGy

PKA

mGy⋅cm2

CTDIvolmGy

DLP

mGy⋅cmAdministered activity

MBq

1
2
3
4
5
6
7
8
9
10
11

*For mammography and tomosynthesis, the recommended DRL quantity is one or more of Ka,e, Ka,ior DG, with the choice of quantity depending on local practices.

12

2.4. Procedure selection

13
14
15
16
17
18
19
20
21

(94)
Procedure selection is important in ensuring DRLs are fit-for-purpose. Whendata on DRL quantities are collected, it is important that all of the data come from proceduresthat are similar across all participating facilities. This ensures that comparisons among
facilities remain valid and useful. There are two aspects to this. First, it is important to specify
in detail both the views normally included [e.g. PA and lateral (LAT) chest radiographs].
Second, the clinical task associated with the procedure should be specified. This is important
where different exposure factors, different views, or different numbers of views are employedfor different clinical indications. A decision would then be required as to whether the DRL
value would be based on all exposures or only a specific subset.

22
23

(95)
Organisations that conduct surveys of DRL quantities will also need toconsider whether or not to distinguish between those procedures performed within a dedicated,(93)
Calibrations of meters and displays should be verified, preferably at intervalsof 1-2 years. Calibration of instruments used to confirm the accuracy of PKA meters, CT
scanner displays of CTDIvol and DLP, and TLDs used for patient dosimetry should be
performed regularly and should be traceable to a national or international standard.
Measurements of equipment output and other exposure variables should be carried out as partof standard QA programmes. Constancy tests should be performed at least annually on all
medical equipment that emits x rays, except that a three-year interval may be employed for
dental radiography equipment. This exception does not include dental cone-beam CT units.

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DRAFT REPORT FOR CONSULTATION: DO NOT REFERENCE

1
2
3

fixed x-ray facility and those performed using mobile equipment. Often the latter provide
unique challenges to the radiographer that may affect the amount of radiation delivered andthus, potentially, the DRL.

4

2.5. Data collection methods

5
6
7
8
9

(96)
There are various options for data collection. If database facilities forautomated recording are limited, paper forms tailored to the examination may be used. These
are time consuming for the operator to complete, and the validity of the results depends on theaccuracy of data entry and subsequent data transfer. This method was used for many years in
the U.K., other European countries, and the U.S. (FDA, 1984).

10
11
12
13
14
15
16
17
18

(97)
The advent of Hospital Information Systems (HIS) and Radiology Information
Systems (RIS) has allowed review of patient examination data to be performed retrospectively.
RIS data collection has the advantage that far greater numbers of patients can be included, but
results may be for multiple views such as PA and LAT projections in radiography. The results
also rely on the accuracy and consistency of data entry, particularly with regard to the proper
identification of the procedure and the correct units for the dosimetric quantities, and may notinclude patient weight. Because much larger numbers of patients can be included in datacollected via a RIS, these problems can be overcome, to some extent, through the exclusion ofoutliers.

19
20
21
22
23
24
25
26

(98)
Modality Performed Procedure Step (MPPS) services can send x-ray procedure,
patient and image information from Digital Imaging and Communications in Medicine(DICOM) headers to the HIS/RIS server upon completion of the examination (Ten et al.,2015; Vano et al., 2008, 2013). Collation of data in Radiation Dose Structured Reports(RDSRs) allows access to procedure data in a structured format and can be used to notify
clinical staff and medical physicists when dosimetric quantities exceed pre-set levels. This
allows for convenient and systematic follow-up of patients at risk of developing tissue
reactions such as skin injuries (Fernandez-Soto et al., 2015).

27
28
29
30
31
32
33
34

(99)
Another option that will become more widely available in the future is the useof data from Picture Archiving and Communication Systems (PACS). Exposure data recordedin the RDSR, MPPS or the DICOM header can be transmitted to the PACS. Currently, data
access is not straightforward, but patient dose management systems are now available whichfacilitate the establishment of databases as repositories of dosimetric data in the future (Cooket al., 2011; Sodickson et al., 2012; Ikuta et al., 2012; Charnock et al., 2013; Vano et al.,2013). Alternatively, dosimetric data can be transmitted to a separate, stand-alone data archive
intended to aid in radiological protection QA and quality improvement.

35
36
37
38

(100)
As programmes for collection and analysis of dosimetric data become moreestablished, the number of examinations and patients included in surveys can be expanded.
For example, the U.K. now has a system whereby dosimetric data collected by medical
physicists in hospitals throughout the U.K. are sent to PHE for collation and analysis. The

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1
2
3
4
5
6

U.K. survey performed in 2010 collected data for 165,000 Ka,e measurements for radiographs,
185,000 PKA measurements for radiographs and 221,000 PKA measurements for fluoroscopy(Hart et al., 2012). Similarly, the American College of Radiology’s Dose Index Registry has
used automated methods to collect data on more than 5 million CT examinations (BhargavanChatfield et al., 2013; Spelic et al., 2009). Regardless of the data source used, the validity ofthe dosimetric indicators must be verified by calibration.

7

2.6. Determining DRL values

8

2.6.1. Distributions of DRL quantities

9
10
11
12
13

(101)
Once a patient survey of DRL quantities is complete, a decision must be madeabout how national or regional DRL values will be set. If the data for each facility relate to alimited number of 20-50 patients within a specified range of patient characteristics, then the
median value of the DRL quantity from each facility can be derived from the distribution of
the dosimetric data for each type of examination.

14
15
16
17
18
19
20
21
22
23

(102)
If large numbers of patients have been included from an electronic datacollection system, then the distribution should first be reviewed to identify obvious outlierswith nonsensical values for DRL quantities. These outliers should be removed. A few highvalues, either from incorrect data entry or exceptionally large patients, could have asignificant effect on the mean of the distribution, but should have minimal influence on the
median. If specialised software for the task is not available, unusual results in the high andlow tails of the distribution can be identified by viewing the ordered distribution in a
spreadsheet or graphically (Fig. 2.1). The data points in the highest and lowest 5% tails of the
distribution can be excluded, but will have minimal effect on the median value for eachfacility. Results can then be included in a distribution of facility-related median values.

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1
2
3
4
5
6
7
8
9
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Fig. 2.1. Examples of data on DLP for chest-abdomen-pelvis scans on three CT scanners
operating under automatic tube current modulation plotted sequentially in terms of increasing
DLP (Martin, 2016). Outliers can be identified readily and omitted from the data analysis.

14
15
16
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18

(104)
The form of the skewed pattern of the distribution of a DRL quantity has been
repeated many times in surveys throughout the world, from many different types of
examinations and for many DRL quantities (Shrimpton et al., 1986, Kwon et al., 2011; Miller
et al., 2011), as there are inevitably always a few facilities where optimisation has not been
fully implemented.

19
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23
24

(105)
DRL values have often been defined as the 75th percentile (third quartile) of
the distribution. This can easily be understood at the national level with a large sample offacilities. The 75th percentile has been chosen as an initial separator between acceptable andexcessive values, but it is arbitrary and has no real scientific basis. However, the 75th
percentile usually lies well below the high dose ‘tail’ of the distribution and serves as a usefulmarker for identification of facilities whose results lie towards the upper end of the(103)
Typical distributions of values of DRL quantities obtained from multiple
facilities are approximately log-normal, and often contain data from a few facilities with
uncommonly high values. The distribution of individual values of entrance surface dose per
image from two types of radiographic examinations for patients from 20 hospitals in an earlysurvey of English hospitals is shown in Fig. 2.2. The data from two hospitals with very low
and very high values of entrance surface dose per image are highlighted. In the early days ofan optimisation programme, it is these hospitals and clinics that need to be identified andtargeted for optimisation.

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distribution. It is reasonable to set the DRL value at the 75th percentile of the distribution, andthe Commission now recommends this practice.

3

4
5
6
7
8

Fig. 2.2. Distributions of entrance surface dose per image for patients from 20 English
hospitals included in an early survey performed by NRPB (now PHE) (Shrimpton et al., 1986).
Distributions for the hospitals with the highest and lowest mean values are highlighted.
[PERMISSION FROM PUBLIC HEALTH ENGLAND IS NECESSARY]

9
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(106)
DRL values are not static. The radiation administered to patients forradiological examinations is expected to decrease as emphasis is placed on optimisation ofprotection and as equipment improves. This has been demonstrated in U.K. surveys ofradiography (Fig. 2.3) and fluoroscopy (Hart et al., 2012). As optimisation occurs and practice
improves, DRL values require periodic updating.

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Fig. 2.3. 3rd quartile Ka,e measurements for radiographic examinations derived from
NRPB/HPA surveys between 1985 and 2010 (taken from Hart et al., 2012). [PERMISSION
FROM PUBLIC HEALTH ENGLAND IS NECESSARY]

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(107)
Findings from a recent survey of CT doses for hospitals throughout Scotland
have revealed a different pattern from the log-normal distributions of DR quantities seen
previously, and may demonstrate a new trend (Sutton et al., 2014). The number of CT
scanners is more limited than other types of x-ray equipment, and in the U.K., there are morediagnostic radiology physicists engaged in optimisation of CT examinations. Since CT
scanning is a relatively high dose imaging method, it has received a high priority for
optimisation efforts. As a result, the majority of dosimetric measurements in the latest
Scottish survey have started to cluster around a position just below the national DRL (Sutton
et al., 2014). This has resulted in the high dose tail of the distribution disappearing. It may
represent a particular circumstance where significant effort has been put into optimisation.
However, it could represent a trend that will extend to other imaging modalities as dosimetric
information becomes more readily available, the number of medical physicists involved indiagnostic radiology increases, and there is more widespread implementation of DRLs.

18

2.6.2. Use of national median values for optimisation

19
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23

(108)
The simple pooling of dosimetric data from surveys to derive DRL values is nolonger completely satisfactory and may result in values of DRL quantities just below the DRL(Sutton et al., 2014) that do not represent true optimisation. A more proactive approach isneeded to ensure the required level of image quality with optimisation of radiologicalprotection. The establishment of a second quantity has been proposed, previously called AD,

2
3

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which represents a level that could be achieved with reasonable practices (NRPB, 1999;
NCRP, 2012). The use of the median value of the distribution used to determine the DRL
value can serve as an additional tool to aid in optimisation. It potentially provides a better
guide for judging good practice as optimisation efforts continue, since the DRL value is the
3rd quartile of the distribution. This median value can be used, along with the DRL value, toassist in optimising image quality and patient dose. Median values may provide a better
alternative for this task than setting further local DRLs for examinations where a national
DRL is available, as discussed in Section 2.3.1.

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(109)
The purpose of a DRL is to identify facilities where investigation of practices
is advisable because protection is not optimised, that is, where the local median value of the
DRL quantity is greater than the national or regional DRL value. However, at facilities where
median facility values of DRL quantities are below the national or regional DRL value,
improvement may still be possible, and staff with the experience necessary to take theoptimisation process further forward may be present. The Commission recognises that medianvalues from the national or regional DRL survey provide an additional benchmark against
which such facilities can evaluate their performance. Since local median values of DRL
quantities at most centres will be below the national DRL value, the national median value
provides a reasonable goal towards which to aim with standard techniques and technologies.

19
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21
22
23
24
25

(110)
Good practice with regard to patient doses would be to attempt to achieve andmaintain a median value of DRL quantities from local surveys at or below the national
median value (NCRP, 2012). When implementing such dose reduction strategies, it is of theutmost importance to ensure that image quality remains commensurate with the clinicalpurpose of the examination (Section 2.7). If local median values of DRL quantities are too
low, image quality (or diagnostic information, when multiple images are used) may beinadequate.

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31
32
33
34
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36
37

(111)
If local median values of the DRL quantity are below the national medianvalue, image quality should be considered as a priority in the optimisation process. The basis
for this recommendation is that the national median value is the midpoint of the distribution of
the data for the DRL quantity determined from surveys of many facilities. If practices at the
local facility have already achieved levels of administered radiation that are below thenational median value, further reduction in administered dose is not the principal concern.
When local practices result in levels of administered radiation that are below average, image
quality is a priority, and further optimisation of protection by reduction of administeredradiation is secondary. Patient dose must not be reduced so much that the images become
non-diagnostic. Dose reduction is not an end unto itself. The adequacy of the image isparamount. Image quality must never be reduced to the point where there is a risk that it is not
sufficient for the medical imaging task.

38

2.6.3. Establishing regional DRL values

39
40

(112)
Some regions of the world (such as the European Union) are trying toharmonise the radiation safety aspects of their health care systems. A requirement for regional

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4

DRLs may be included in regional guidelines or regulations (e.g. European Directives).
Countries in these regions may or may not already have national DRLs. As a result, theCommission is offering guidance on how to set regional DRL values. There are several
options.

5
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7
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9

(113)
Regional DRL values may be based on a single survey of a representative
sample of facilities drawn from the entire region, or on national DRL values derived fromseparate national surveys. The specific method for setting a regional DRL value depends onwhether it is based on data from a single regional survey of a representative sample offacilities or on national DRL values.

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(114)
When national DRL values exist for many or most countries within a region,
the simplest and easiest method for establishing regional DRL values is to use the national
DRL values as the basis for the regional values. Since the national values typically represent
the 75th percentile values for the national distributions of DRL quantities, the median of theavailable national DRLs should approximate the 75th percentile value to be expected from a
regional patient survey. The mean of the available national DRL values should not be used, as
this method could result in excessive variation in regional DRL values if some of thecountries in the region have very low or very high national DRL values.

18
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22

(115)
When relatively few national DRL values exist for the countries within aregion, regional DRL values may be derived through a consensus of the region’s competentauthorities. This process should take into account existing national DRL values, but should
also consider that a median that is derived from only a small number of national DRL values
could be inappropriate.

23
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25
26
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32

(116)
Using existing national DRL values as the basis for regional DRL values isefficient, but not ideal. This approach may overemphasise the survey data from smaller
countries and countries where a relatively small number of facilities and patients are surveyed.
Conversely, it may underemphasise the survey data from larger countries and countries wherea relatively large number of facilities and patients are surveyed. This problem can be dealt
with when calculating regional DRL values by weighting national DRL values according to
the population of each participating country. However, the most accurate DRL values will beobtained from a single survey of a random sample of facilities throughout the region.
Fortunately, this degree of accuracy is unlikely to be necessary, given that the purpose of a
DRL is only to indicate when an investigation of local practices is necessary.

33

2.7. Image quality

34
35
36
37
38

(117)
The approach used most frequently in discussions among physicists,
radiologists, and radiographers on how to accomplish optimisation of protection is to achievecompliance with the DRL value for the examination. However, DRL quantities are notdescriptors of image quality. Median values of DRL quantities at a health centre that are
above or below a particular value do not indicate that images are adequate or inadequate for a

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particular clinical purpose. Substituting compliance with national DRL values for evaluationof image quality is not appropriate.

3
4
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7

(118)
The highest priority for any diagnostic examination is achieving image quality
sufficient for the clinical purpose, so that the images from the whole procedure provide all the
diagnostic information required and the clinical purpose is not jeopardised. This does notmean that every image is of high quality; for some modalities (e.g. fluoroscopy), a series ofimages, each of poor quality, may together provide the necessary clinical information.

8
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10
11
12
13
14
15

(119)
Administered radiation doses that are so low that image quality is inadequate
are as unacceptable as administered radiation doses that are too high. When image quality isinadequate for the clinical purpose, the administered radiation provides no clinical benefit, theexamination must be repeated, and the patient receives additional radiation from the repeatedexamination. Because data from patient surveys are gathered from clinical sites, it has been
assumed that the pooling of data on DRL quantities provides information on administeredradiation doses that the majority of radiologists agree with to produce images that are
sufficient for the clinical purpose.

16
17
18
19
20
21

(120)
A focus on DRL quantities alone, without image quality criteria, could drive
the value of the DRL ever downward, so that at some stage, image quality could becompromised. It is essential to assure that image quality appropriate for the diagnostic
purpose is achieved when modifying imaging protocols. Therefore, optimisation must balance
image quality and patient dose. Image quality must be maintained at an appropriate level as
the amount of radiation is decreased.

22
23
24
25
26
27
28
29

(121)
Prior to collection of DRL data, surveyors should ensure that imaging
equipment is functioning acceptably and providing clinical images that are of a quality
appropriate for the clinical task. Evidence-based criteria for judging image quality should be
employed whenever possible. Guidance on the level of image quality required for different
imaging tasks is limited. The EC (1996a, b, 1999b) has produced guidelines with criteria thatcan be used for scoring images when judging their diagnostic potential. These or similar
criteria can be used for assessing image quality whenever changes are made that could affectimage quality.

30
31
32
33
34
35

(122)
Additional substantive data on appropriate image quality parameters fordifferent examinations are needed. To aid in this process, more detailed analyses of acceptablelevels of image quality for CT and other specialties are needed. Involvement of radiologists isnecessary to evaluate clinical images using clinical image criteria. Additional data are also
required on the magnitude of objective image quality variables linked to clinical imaging
tasks.

36
37
38

(123)
Chest radiography, where adequate image quality is required for both low andhigh attenuation regions, is a particular challenge and is the subject of a report by ICRU
(1995).

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3
4
5
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8

(124)
Restrictions on dose have been imposed in the past by the sensitivity offilm/screen systems for radiography; recommendations on the appropriate speed class forgeneral use resulted in a restriction on dose. Also, film blackening at high doses madeexcessive exposures obvious and deterred overexposure. Similar restrictions are not present
with digital radiography or CT scanning. Hence, monitoring exposure parameters in CT anddigital radiography and the exposure index in computed radiography is essential. The balance
between image quality and patient dose is essential. Appropriate postprocessing may permit
the use of lower exposure levels.

9
10
11
12
13
14
15

(125)
There may be less agreement among radiologists regarding the appropriate
level of image quality for CT examinations. The various factors that contribute to image
quality should be discussed when CT and other digital imaging protocols are set up for a newscanner. The factors involved relate to (1) the contrast of the displayed image, as determinedby window level and width, and (2) spatial resolution, in terms of focal spot size and thereconstruction kernel for digital filters. A report on image quality and dose assessment in CT
has been prepared by ICRU (2012).

16
17
18
19
20
21
22
23

(126)
Various metrics have been used for some time to characterise image contrast
and the performance of imaging systems. These require specialist measurement techniques
and are provided by the manufacturer for most imaging systems. Techniques through which
hospital medical physicists can make these measurements are becoming more widely
available. These metrics include modulation transfer function (MTF), the system transfer
factor (K), and noise power spectra (NPS) (ICRU, 1995). They should provide useful
information to the medical physicist to aid in selection of appropriate image quality levels as
part of the optimisation process for digital imaging systems in the future.

24

2.8. References

25
26
27

Administration of Radioactive Substances Advisory Committee (2006) Notes for Guidance on
the Clinical Administration of Radiopharmaceuticals and Use of Sealed Radioactive
Sources. Health Protection Agency: Chilton.

28
29
30
31
32

Balter, S., Miller, D.L., Schueler, B.A., Cole, P.E., Berenstein, A., Albert, R., Georgia, J.D.,
Noonan, P.T., Russell, E.J., Malisch, T.W., Vogelzang, R.L., Geisinger, M., Cardella, J.F.,
St George, J., Miller, G.L., III, Anderson, J., 2004. Radiation doses in interventional
radiology procedures: The RAD-IR study. Part III. Dosimetric performance of thefluoroscopes. J. Vasc. Interv. Radiol. 15, 919–926.

33
34

Bhargavan-Chatfield, M., Morin, R.L., 2013. The ACR Computed Tomography Dose Index
Registry: the 5 million examination update. J. Am. Coll. Radiol. 10, 980–983.

35
36

Charnock, P., Moores, B.M., Wilde, R., 2013. Establishing local and regional DRLs by meansof electronic radiographical x-ray examination records. Radiat. Prot. Dosim. 157, 62–72.

37
38

Conference of Radiation Control Program Directors. 2003. Use of radionuclides in the healing
arts. In: Suggested State Regulations for Control of Radiation, Volume I, (Ionising52

DRAFT REPORT FOR CONSULTATION: DO NOT REFERENCE

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2

Radiation)
Part
G,
CRCPD
http://www.crcpd.org/SSRCRs/gpart.pdf.

dynamic

document.

Available:

3
4
5

Cook, T.S., Zimmerman, S.L., Steingall, S.R., Maidment, A.D., Kim, W., Boonn, W.W.,
2011. Informatics in radiology: RADIANCE: an automated, enterprise-wide solution forarchiving and reporting CT radiation dose estimates. Radiographics 31, 1833–1846.

6
7

EC, 1996a. European guidelines on quality criteria for diagnostic radiographic images. EUR
16260 EN. European Commission, Luxembourg.

89EC, 1996b. European guidelines on quality criteria for diagnostic radiographic images inpaediatrics. EUR 16261 EN. European Commission, Luxembourg.

10EC, 1999a. Guidance on diagnostic reference levels for medical exposures. Report 109.

11
12
13

EC, 1999b. Quality Criteria for Computed Tomography (Report EUR 16262 EN).
Luxembourg:
EuropeanCommission.
http://www.drs.dk/guidelines/ct/quality/mainindex.htm

14
15
16
17

EC, 2008. European Guidance on Estimating Population Doses from Medical X-Ray
Procedures. Radiation Protection No. 154 TREN/04/NUCL/S07.39241 (Health Protection
Agency:Chilton,UK),
http://ec.europa.eu/energy/nuclear/radiation_protection/publications_en.htm.

18
19
20
21

EC, 2014. Radiation Protection No. 180. (Part 1) - Medical Radiation Exposure of theEuropean Population. (Part 2) Diagnostic Reference Levels in Thirty-six European
Countries. Luxembourg: European Commission. https://ec.europa.eu/energy/en/radiationprotection-publications

22
23
24

Fernandez-Soto, J.M., Ten, J.I., Sanchez, R.M., España, M., Pifarre, X., Vano, E., 2015.
Benefits of an automatic patient dose registry system for interventional radiology andcardiology at five hospitals of the Madrid area. Radiat. Prot. Dosim. 165, 53–56.

25
26
27

FDA, 1984. Nationwide Evaluation of X-Ray Trends (NEXT) eight years of data (1974-1981).
U.S. Department of Health and Human Services, Public Health Service, Food and Drug
Administration.

28
29
30

Goenka, A.H., Dong, F., Wildman, B., Hulme, K., Johnson, P., Herts, B.R., 2015. CTradiation dose optimization and tracking program at a large quaternary-care health caresystem. J. Am. Coll. Radiol. 12, 703–710.

31
32

Hart, D., Hillier, M.C., Wall, B.F., Shrimpton, P.C., Bungay, D., 1996. Doses to patients frommedical X-ray examinations in the UK— 1995 Review. NRPB-R289, (Chilton: NRPB).

33
34

Hart, D., Jones, D.G., Wall, B.F., 1996. Coefficients for estimating effective doses frompaediatric X-ray examinations. NRPB-R279. NRPB, Chilton. (and CHILDOSE)

35
36
37

Hart, D., Hillier, M.C., Shrimpton, P.C., 2012. Doses to Patients from Radiographic andFluoroscopic X-ray Imaging Procedures in the UK – 2010 Review Report HPA-CRCE034 (HPA: Chilton).

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DRAFT REPORT FOR CONSULTATION: DO NOT REFERENCE

1
2

ICRP, 1996. Radiological protection and safety in medicine. ICRP Publication 73. Ann. ICRP
26(2).

3
4

ICRP, 2013. Radiological protection in paediatric diagnostic and interventional radiology.
ICRP Publication 121. Ann. ICRP 42(2).

56IPEM. (2005). Commissioning and routine testing of mammographic X-ray systems. Report
No. 89, IPEM, York.

7
8
9
10

Ikuta, I., Sodickson, A., Wasser, E.J., Warden, G.I., Gerbaudo, V.H., Khorasani, R., 2012.
Exposing exposure: enhancing patient safety through automated data mining of nuclear
medicine reports for quality assurance and organ dose monitoring. Radiology 264, 406–
413.

11
12

ICRU, 1986. Modulation transfer function of screen film systems (Report 41).
ICRU:Bethesda, MD.

13
14

ICRU, 1995. Medical Imaging - The Assessment of Image Quality (Report 54)
ICRU:Bethesda, MD.

15
16

ICRU, 2003. Image Quality in Chest Radiography (Report 70) Oxford University Press:
ICRU.

17
18

ICRU, 2012. Radiation dose and image quality and image-quality assessment in computed
Tomography (Report 87). Oxford University Press: ICRU.

19
20

IPEM, 2004. Guidance on the establishment and use of diagnostic reference levels for
medical X-ray examinations. IPEM Report 88 (IPEM, York).

21
22

IPSM/NRPB/CoR. (1992). National protocol for patient dose measurements in diagnostic
radiology. NRPB, Chilton.

23
24
25

Kwon, D., Little, M.P., Miller, D.L., 2011. Reference air kerma and kerma-area product asestimators of peak skin dose for fluoroscopically guided interventions. Med. Phys. 38,
4196–4204.

26
27

MacGregor, K., Li, I., Dowdell, T., Gray, B. G., 2015. Identifying institutional diagnostic
reference levels for CT with radiation dose monitoring software. Radiology 276, 507–517.

28
29

Martin, C.J., 2011. Management of patient dose in radiology in the UK. Radiat. Prot. Dosim.
147, 355–372.

30
31Martin, C.J., 2008. Radiation dosimetry for diagnostic medical exposures. Radiat. Prot.
Dosim. 128, 389–412.

32
33

Martin, C.J., 2016. The application of diagnostic reference levels for optimisation of x-ray
imaging in the UK. Radiat. Prot. Dosim. (in press, doi: 10.1093/rpd/ncv433).

34
35
36

Martin, C.J., Le Heron, J., Borrás, C., Sookpeng, S., Ramirez, G., 2013. Approaches to
aspects of optimisation of protection in diagnostic radiology in six continents. J. Radiol.
Prot. 33, 711–734.

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DRAFT REPORT FOR CONSULTATION: DO NOT REFERENCE

1
2
3

Miller, D.L., Balter, S., Cole, P.E., Hollington, T., et al., 2003. Radiation doses ininterventional radiology procedures: The RAD-IR study Part II. Skin dose. J. Vasc. Interv.
Radiol. 14, 977–990.

4
5
6

Miller, D.L., Kwon, D., Bonavia, G.H., 2009. Reference levels for patient radiation doses ininterventional radiology: proposed initial values for U.S. practice. Radiology 253, 753–
764.

7
8
9

NCRP, 2012. Reference levels and achievable doses in medical and dental imaging:recommendations for the United States. NCRP Report No. 172. National Council on
Radiation Protection and Measurements, Bethesda, MD.

10
11
12

Neil, S., Padgham, C., Martin, C.J., 2010. A study of the relationship between peak skin doseand cumulative air kerma in interventional neuroradiology and cardiology. J. Radiol. Prot.
30, 659–672.

13
14
15

Notghi A, Williams N, Smith N, Goyle S, Harding LK (2003) Relationship between
myocardial counts and patient weight: adjusting the injected activity in myocardial
perfusion scans. Nucl. Med. Commun. 24, 55–59.

16
17
18

NRPB, 1999. Guidelines on patient dose to promote the optimisation of protection for
diagnostic medical exposures. Documents of the NRPB 10(1). National RadiologicalProtection Board, Chilton.

19
20
21

Piepsz, A., Hahn, K., Roca, I., Ciofetta, G., Toth, G., Gordon, I., Kolinska, J., Gwidlet, J.,
1990. A radiopharmaceutical schedule for imaging in paediatrics. Eur. J. Nucl. Med. 17,
127–129.

22
23
24
25

Shrimpton, P.C., Wall, B.F., Jones, B.J., Fisher, E.S., Hillier, M.C., Kendall, G.M., Harrison,
R.M., 1986. National survey of doses to patients undergoing a selection of routine x-ray
examinations in English hospitals. National Radiological Protection Board Report,
NRPB-R200 (HMSO, London).

26
27
28

Shrimpton, P.C., Wall, B.F., Hillier, M.C., 1989. Suggested guideline doses for medical
examinations. In: Radiation Protection – Theory and Practice, Proc. 4th International
Symposium of the Society of Radiological Protection 1989, Malvern, UK pp. 85–88.

29
30
31
32

Sodickson, A., Warden, G.I., Farkas, C.E., Ikuta, I., Prevedello, L.M., Andriole, K.P.,
Khorasani, R., 2012. Exposing exposure: automated anatomy-specific CT radiation
exposure extraction for quality assurance and radiation monitoring. Radiology 264, 397–
405.

33
34
35
36

Spelic, D.C., CRCPD Committee on Nationwide Evaluation of X-ray Trends, 2009.
Nationwide Evaluation of X-ray Trends (NEXT) protocol for 2008-2009 survey of cardiac
catheterization. CRCPD Publication #E-09-2. Conference of Radiation Control Program
Directors, Inc., Frankfort, KY, p. 53.

37
38
39

Sutton, D.G., McVey, S., Gentle, D., Hince, A.J., MacDonald, N., McCallum, S., 2014. CTchest abdomen pelvis doses in Scotland: has the DRL had its day? Br. J. Radiol. 87,
20140157.

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Ten, J.I., Vano, E., Sánchez, R., Fernandez-Soto, J.M., 2015. Automatic patient dose registry
and clinical audit on line for mammography. Radiat. Prot. Dosim. 165, 346–349.

3
4
5

Vaño, E., Fernández, J.M., Ten, J.I., Prieto, C., González, L., Rodríguez, R., de las Heras, H.,
2007. Transition from screen-film to digital radiography: evolution of patient radiation
doses at projection radiography. Radiology 243, 461–466.

6
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8

Vano, E., Ten, J.I., Fernandez, J.M., Prieto, C., Ordiales, J.M., Martinez, D., 2008. Quality
control and patient dosimetry in digital radiology. On line system: new features andtransportability. Radiat. Prot. Dosim. 129, 144–146.

9
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Vano, E., Ten, J.I., Fernandez-Soto, J.M., Sanchez-Casanueva, R.M., 2013. Experience withpatient dosimetry and quality control online for diagnostic and interventional radiology
using DICOM services. AJR Am. J. Roentgenol. 200, 783–790.

12Wall, B.F., 2005. Implementation of DRLs in the UK. Radiat. Prot. Dosim. 114, 183–187.

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3.

2

RADIOGRAPHY AND DIAGNOSTIC FLUOROSCOPY

3
4
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6

•

DRL quantities should be easily assessed, preferably from a direct measurement
for the examination. Either PKA or Ka,e may be used for radiography. PKA also
takes account of collimation.

7•

For mammography, the recommended DRL quantity is one or more of Ka,i, Ka,eor DG, with the choice of quantity depending on local practices.
While PKA and Ka,r are the recommended DRL quantities for fluoroscopy,
setting DRL values for fluoroscopy time and the number of cine or digital
subtraction angiography (DSA) images is also recommended.
Phantoms may provide a convenient first step for evaluating the performance of
mammography, radiography and fluoroscopy equipment, but their use should
not replace patient surveys.
A convenient method for setting DRL values for dental radiography is to use
measurements of air kerma at the cone tip, the point at which x rays are incident
on the skin, made with standard settings that are used in clinical practice.
Separate measurements should be made for adults and children.
For panoramic dental radiography, PKA can be measured with an ionisationchamber, or the dose-width product can be measured with a detector positioned
at the receiving slit.

8
9

•

10
11
12

•

13
14
15

•

16
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•

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3.1. Radiography and diagnostic fluoroscopy examinations(127)
Radiography and diagnostic fluoroscopy include a wide range of examinations,but obtaining reasonable and sufficient data is only practical for those examinations mostcommonly performed. Nevertheless, these results should influence the technical factors used
for other examinations. Optimisation efforts should be prioritised based on the potential riskof stochastic effects to patients, and priority given to those that result in substantial organ
doses to radiosensitive organs.

30
31
32
33
34

(128)
The examinations chosen for surveying should be those performed mostfrequently in the region for which dose assessment is practicable. They should also
encompass the different techniques and equipment that are used. Table 3.1 gives the relative
frequencies of various medical radiography and fluoroscopy examinations and theircontributions to the collective effective dose for ten European countries.

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2
3

Table 3.1. Relative frequencies of different diagnostic radiographic and fluoroscopic examinations andinterventional procedures and percentage contributions to collective effective dose from radiology(data taken from EC, 2008).
Examination

Percentage of totalfrequency of allradiology exams

Percentage
contribution tocollective dose

Chest/thorax

12-29%

0.7-5.2%

Mammography

0.3-15%

0.6-4.7%

Abdomen, pelvis and hip

7.4-14.3%

2.9-14.1%

Spine (thoracic and lumbar)

3.8-12.7%

30.1%

Intravenous urography

0.3-2.0%

1.2-8.7%

Barium meal

0.3-0.9%

0.8-5.9%

Barium enema

0.1-2.0%

0.5-13%

Cardiac angiography

0.2-1.3%

2.8-9.4%

Radiography

Radiography/fluoroscopy

4
5
6
7
8
9

(129)
In many countries, the most common radiographic examination is chest
radiography (EC, 2008). Since chest radiography is a very common examination and involves
exposure of several radiosensitive organs, it should be included in surveys of radiography.
The largest contributions from radiography to collective effective dose are examinations of
the abdomen, pelvis and spine, so these should also be included in any radiographic survey.

10
11
12
13

(130)
It is recommended that skull x rays be included, as they involve exposure of
the lens of the eye, and mammography because the breast is one of the sensitive organs.
Moreover, these examinations employ different techniques, and the settings used will notnecessarily reflect those for other procedures.

14
15
16
17
18

(131)
The upper and lower extremities are examined frequently. However, these
examinations are usually limited to a portion of the extremity, and the only radiosensitive
organs exposed are parts of the bone marrow and skin. Thus, the estimated contribution toradiation risk is small. As a consequence, setting DRLs for these examinations is a lower
priority, but optimisation is still necessary.

19
20
21
22
23

(132)
Similar arguments can be applied to the choice of diagnostic fluoroscopy
examinations to be studied. More common procedures are included in Table 3.1, but sincepractices vary in different healthcare facilities as well as in different parts of the world, those
appropriate for the country/region/facility where the DRLs are to be applied should be
reviewed in making the selection.

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4

3.2. DRL quantities for radiography(133)
The DRL quantity should be one that is easily assessed, preferably from a
direct measurement for the examination. Either PKA or Ka,e may be used (Table 2.3), but
assessment of both is preferable, when possible, in order to simplify evaluation of collimation.

5
6
7
8
9
10
11

(134)
PKA is ideal for radiography and fluoroscopy, as it includes all the radiation
incident on the patient (assuming that the radiation field is collimated appropriately to thepatient). Since PKA is determined by both air kerma and the size of the radiation field, it takes
into account all factors influencing patient radiation dose. It should be readily available inthose systems where a PKA meter is installed or the system calculates PKA. It should be notedthat PKA results are influenced by whether or not the x-ray beam passes through the patient
couch.

12
13
14
15
16
17
18

(135)
Although PKA values recorded by meters, calculated by the equipment, or
given by the manufacturers and reported in the DICOM header should be reasonably accurate,
there is no way to guarantee this. Patients could be receiving substantially higher values of
PKA than would appear to be the case unless the metered, calculated or provided values areverified periodically. The Commission recommends that an arrangement be in place to checkthe calibration of PKA meters and the accuracy of PKA values calculated and displayed by the
x-ray equipment and recorded in the DICOM header.

19
20
21
22
23
24
25
26

(136)
When no PKA value is available, Ka,e (including backscatter) should be used asa tool for radiography. Ka,e can be measured on clinical images using dosimeters such asradiolucent thermoluminescent dosimeters (TLDs), as long as they do not interfere with theimages. Alternatively, Ka,e can be calculated from knowledge of the exposure factors (kVp,
mAs) and source-to-skin distance (SSD), combined with measurements of the x-ray unit
output and a correction for the addition of backscatter. This is perhaps the simplest approachto take, since it involves less additional equipment, but it does require a measurement of x-ray
unit output to be made.

27
28
29
30
31
32

(137)
In countries where resources are very limited, it is possible to base a
calculation of Ka,e on tabulated values of output per mAs at the appropriate tube potential,
but this will reduce the accuracy by 20-30%, because the output varies with voltage waveform,
anode angle, filtration and any damage to the anode, all of which will have to be estimated(Martin and Sutton, 2014; Le Heron, 1989). Results that could be used are given in Table 3.2,
but it is strongly recommended that measurements be made wherever possible.

33
34

Table 3.2. Radiographic outputs (µGy/mAs at 1 metre, with 3.0–3.6 mm aluminium equivalentfiltration).
WaveformakVp
2 pulse6 and 12 pulsea
Constant potentialb
70
20 ± 636 ± 1042 ± 580
28 ± 850 ± 1359 ± 69035 ± 1070 ± 18100
43 ± 1294 ± 2290 ± 9ab
Sources of data: Le Heron (1989), Martin and Sutton (2014).

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DRAFT REPORT FOR CONSULTATION: DO NOT REFERENCE

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2
3
4
5
6
7
8

(138)
In any event, the kV, mAs, and SSD or some method of deriving it should be
included to allow calculation of Ka,e. The dose detector index (DDI) displayed on digitalsystems, which relates to the amount of light generated from the phosphor, should also berecorded. The method of image recording (CR, DR or film), the system model andmanufacturer for digital radiography, the film speed or equivalent and whether the exposure
was under AEC should be noted for each room and type of examination whenever possible, toprovide information for use in optimisation.

10
11
12
13
14

3.3. DRL quantities for fluoroscopy(139)
PKA should always be used to set DRLs for fluoroscopic examinations, if it isavailable (Table 2.3). Many fluoroscopy units display both cumulative air kerma (Ka,r) at thepatient entrance reference point (IEC, 2010) and PKA. If Ka,r is available, it should also be
used to set DRLs for specific diagnostic examinations, because comparison of Ka,r and PKA
values is useful in judging beam collimation.

15
16
17
18
19
20
21
22

(140)
For diagnostic fluoroscopy procedures, fluoroscopy time and numbers of cineor DSA images should also be recorded in surveys. DRLs based on these quantities are usefulas a guide to good practice and as an aid in optimisation. Where no facility for displaying or
recording the values of these quantities is available on older fluoroscopy equipment,
fluoroscopy time may be the only option for deriving data. The frame rate for digital
subtraction imaging, the pulse rate for fluoroscopy, the image recording technique andexposure programme options used should be included. Interventional fluoroscopy is discussed
in Chapter 4.

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24
25
26
27
28
29
30
31
32

3.4. Use of phantoms in radiography and fluoroscopy(141)
Slabs of material with properties similar to those of tissue (slab phantoms) areused for measurement of dosimetric performance when AEC is used for radiography (Conway
et al., 1992). For some applications, slabs of polymethylmethacrylate (PMMA) or
polyethylene, or plastic containers filled with water, may be used for assessing the values ofdose quantities employed in patient examinations. While these are not realistic surrogates forpatients, they may be useful for estimating Ka,e for different phantom thicknesses that equate
to patients of different sizes, particularly when exposure factors are selected automatically.
Ka,e (including backscatter) can be measured with a flat plate ionisation chamber placed on
the surface of such a slab phantom and the post exposure mAs recorded.

33
34
35
36
37
38

(142)
Some standard slab phantoms made from PMMA and aluminium have beendeveloped to replicate standard chest, abdomen and lumbar spine examinations (Conway et al.,1992). Here, an attempt is made to achieve a transmitted x-ray beam similar to that for an
examination of the respective body part, so that the operation of the AEC on radiographic
units can be tested. These standard phantoms can be used to compare and assess AEC set-ups
on different x-ray units.

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DRAFT REPORT FOR CONSULTATION: DO NOT REFERENCE

1
2
3
4

(143)
Although phantoms can be helpful in assessing performance of x-ray units
operating in an AEC mode, they should not replace surveys of actual patient examinations.
Data from patient examinations provide the only definitive method for determining values of
DRL quantities during clinical use.

5
6
7
8
9
10

(144)
Slab phantoms can also be used to measure Ka,e rates for different pre-set
protocols on fluoroscopic equipment, to provide information on the performance of thefluoroscope (Martin et al., 1998). The results can be compared to performance criteria, butthese Ka,e rates are not DRL quantities. These measurements can be performed during QA
tests and provide information valuable for constancy testing (Balter et al., 2004) and for theinterpretation of possible causes of high results found in patient surveys.

11
12
13
14
15
16
17
18

3.5. Mammography(145)
In mammography, the only part of the body that receives a significant dose is
the breast. Mammography employs x-ray tube potentials between 25 kV and 32 kV with x-ray
tube anodes and filters made from different materials (e.g. molybdenum, rhodium) than thematerials used in other x-ray systems. Meters used for radiation output measurements for
mammography are specially designed, because of the lower energies of the x rays used. They
require specific calibration with an x-ray spectrum in the range used for mammography,
because of the influence of the attenuation of the entry window.

19
20

(146)
Screening programmes for asymptomatic individuals should use the same DRL
values as for examinations performed to investigate patients with clinical symptoms.

21
22
23
24
25
26
27

(147)
Three DRL quantities have been used for surveys of mammography: Ka,e, Ka,i,and mean glandular dose (DG). For both mammography and breast tomosynthesis, theCommission recommends using one or more of Ka,e, Ka,i, or DG	
   as the DRL quantity, withthe choice of quantity depending on local practices. The Commission suggests using DG as a
DRL quantity, even though it is a measure of organ dose rather than the amount of ionisingradiation used to perform a medical imaging task, due to the large variability of Ka,e and Ka,iwith kV and with different anode/filter combinations, even for the same breast thickness.

28
29
30
31
32
33

(148)
Ka,e was used initially as the DRL quantity. Measurement of Ka,e isstraightforward, and no correction factors are required. It allows direct comparisons among
mammography units with similar anode/filter combinations. However, there are now a variety
of beam qualities resulting from the different materials used for anodes and K-edge filters thatchange the dependence of DG	
   on Ka,e. These differences should be taken into consideration
when comparing results.

34
35
36
37
38

(149)
Ka,i per mAs is derived from output measurements, made with the breast
compression plate in position. This is then multiplied by the mAs used to obtain the Ka,i forthe examination. The Ka,i will depend on the size of the breast; there are substantial variations
among individuals. For this reason, the inclusion of more patients per facility, e.g. 50, is
recommended for patient surveys.

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1
2
3
4
5
6

(150)
DG	
   gives a direct comparison relating to risk for different equipment, and so
has been employed in many parts of the world. The relationship between Ka,i and DG	
   ishighly dependent on breast thickness and composition, as well as beam quality, so there ismore variation in potential risk with the DRL quantities that are measured directly, such as
Ka,i and Ka,e, than for other examinations. This has been a persuasive argument for countries
to use DG	
  to help in optimisation.

7
8
9
10
11
12
13

(151)
DG	
   is calculated from the Ka,i used for the examination for a specified
thickness of compressed breast. The Ka,i and DG	  will depend on the size of the breast and its
composition, which changes throughout a woman’s life. There is extensive literature on theconversion from Ka,i to DG, derived from Monte Carlo calculations for a wide range of beam
qualities. These are a function of beam quality, i.e. half value layer (HVL) thickness,
anode/filter combination, breast thickness and breast composition (Dance et al., 2000; IPEM,
2005).

14
15
16
17
18
19
20
21

(152)
When Ka,e or Ka,i is used as the DRL quantity, evaluation programmearrangements should be based on recommendations by a qualified medical physicist, in orderto ensure that dependence on breast thickness and differences in DG	
   are taken into account.
Phantoms may provide a convenient method to help determine DRL values. However, sincephantoms do not assess the full range of breast sizes for which examinations will be
undertaken, and do not reflect clinical use of the equipment, surveys of patients arerecommended as the main method of evaluating the amount of radiation applied in
mammography.

22
23
24
25
26
27
28
29
30
31
32

(153)
A phantom that is equivalent to the standard breast is used for routine QC in
mammography. The 2006 European guidelines (EU, 2006) suggest imaging PMMA plates ofvarious specified thicknesses and calculating the DG	   for each thickness. In the U.K., thephantom typically might be a semi-circular PMMA phantom, 160 mm in diameter and 45 mm
thick, with which DG	
   may be assessed under AEC using the mAs readout. The 45 mm thick
PMMA breast phantom is equivalent to a 53 mm thick standard breast and can be used tocompare the dosimetric performance of mammography units. DG	
  can be calculated from Ka,emeasured at the surface of the phantom with a suitable calibrated detector using standard
equations and conversion factors (Dance et al., 2000; IPEM, 2005). The DG	
   DRL value
adopted as a comparator for this standard breast by the UK Breast Screening Programme(BSP) is 2.5 mGy.

33
34
35
36
37
38
39

(154)
In the U.S., the standard phantom used for accreditation of mammography
facilities is composed of a PMMA block, a wax insert, and a PMMA disk attached to the topof the phantom. It is intended to mimic the attenuation characteristics of a compressed“standard breast” of 4.2 cm thickness, composed of 50% adipose and 50% glandular tissue.
U.S. Federal regulations limit the DG	
  to the phantom to 3 mGy per image. In 2006, the meanDG	
   was approximately 1.8 mGy with film-screen mammography, and 1.6 mGy for digital
mammography (Spelic et al., 2007).

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3.6. Dental radiography

2
3
4
5
6
7
8

(155)
There are some examinations that are relatively independent of patient size.
Examples are dental intraoral and panoramic imaging, which are usually performed withequipment that has a fixed kV and mA and a timer programmed for dental imaging. For dental
units, dosimetric measurements made by a medical physicist visiting the clinic provide thebest option, rather than measurements on individual patients. Surveys may be carried out by
direct measurement with radiation detectors when QA checks are made on the x-ray units.

9
10
11
12
13
14
15
16

(156)
A convenient method for setting DRL values and evaluating patient dose fordental radiography is to make measurements at standard settings. Intraoral units frequently
have fixed tube potentials and currents, and the exposure is varied by adjusting the exposure
time for the type of tooth under investigation. Exposure time is selected manually either witha dial calibrated for the tooth or by selection of exposure time. Measurements of the incident
air kerma can be made at standard settings with a suitable calibrated detector placed at the endof the spacer cone of the x-ray set (Gulson et al., 2007). This measurement relates to the air
kerma incident on the skin surface.

17
18
19
20
21
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23

(157)
The measurements made must utilise the exposure settings that the dentist uses
regularly. Information must be obtained to confirm the settings. It is recommended that this beobtained before a survey is undertaken, possibly via a short questionnaire sent to the dentist
for completion before the test, seeking this information together with other data on dental xray practices. Different settings will normally be used for adults and children, so dose
measurements and DRL values will be required for both. Further consideration of the use of
DRLs in dental radiography is given in Section 7.1.2.

24
25
26

(158)
The x-ray equipment will normally always be left on the standard“film/detector speed” setting used. However, those testing such equipment should ensure,
before making the measurement, that the dentist confirms that this is the setting actually used.

27
28
29
30
31
32
33

(159)
An alternative survey method that does not require a visit to each dental
facility is the use of calibrated test packs that incorporate film covered by a series of filters
and that can be sent through the post to the dental practice from a central laboratory. These
can evaluate x-ray equipment used with digital receptors as well as x-ray equipment used withfilm. These test packs provide a potential method for remote assessment (Gulson et al., 2007).
However, considerable effort needs to be put into the development and calibration of such asystem, and into ensuring that the dentist is given sufficient instructions in its use.

34
35
36
37
38

(160)
Dentists should have had training in radiography and radiological protection aspart of their education (ICRP, 2009). It is important that this is kept up to date and that it
includes information on the role of DRLs. This should be reinforced through feedback on
results from the dosimetric measurements that are carried out. Periodic refresher training inradiographic techniques and the optimisation of radiological protection is recommended.

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7
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(161)
For panoramic dental radiography, techniques that measure the DRL quantity
from the entire beam are required. PKA can be measured with an ionisation chamber that is
attached to the x-ray tube housing and intercepts the entire beam, as in standard radiography.
Alternatively, smaller detectors (but still broader than the x-ray beam), calibrated in terms ofthe dose-width product (DWP) (mean air kerma in the beam × beam width) and positioned at
the receiving slit, can be used (Holroyd, 2012; Mitchell and Martin, 2013). The DWP can beconverted to PKA through multiplication by the length of the x-ray beam at the receiving slit.
Detectors smaller than the beam width have been used for measurement of the air kerma
within the beam, and the result multiplied by the slit width to give the DWP. However, since
the air kerma varies across the beam, this method is subject to a greater error.

11

3.7. References

12
13

Conway, B.J., Suleiman, O.H., Rueter, F.G., McCrohan, J.L., 1992. Patient equivalentattenuation phantoms. Radiat. Prot. Dosim. 43, 123–125.

14
15
16

Dance, D.R., Skinner, C.L., Young, K.C., Beckett, J.R., Kotre, C.J., 2000. Additional factors
for the estimation of mean glandular breast dose using the UK mammography dosimetry
protocol. Phys. Med. Biol. 45, 3225–3240.

17
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19
20

EC, 2008. European Guidance on Estimating Population Doses from Medical X-Ray
Procedures. Radiation Protection No. 154 TREN/04/NUCL/S07.39241 (Health Protection
Agency:Chilton,UK),
http://ec.europa.eu/energy/nuclear/radiation_protection/publications_en.htm.

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23
24

EU, 2006. European guidelines for quality assurance in breast cancer screening and diagnosis[4th Edition], Luxembourg: Office for Official Publications of the European
Communities. Available at http://www.euref.org/downloads?download=24:europeanguidelines-for-quality-assurance-in-breast-cancer-screening-and-diagnosis-pdf

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26
27

Gulson, A.D., Knapp, T.A., Ramsden, P.G., 2007. Doses to patient arising from dental x-ray
examinations in the UK 2002-2004. A review of x-ray protection service data. HPARPD-022 (HPA: Chilton).

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29

Holroyd, J.R., 2012. The measurement of x-ray beam size from dental panoramic radiographyequipment. HPA-CRCE-032 (HPA: Chilton).

30
31

ICRP, 2009. Education and training in radiological protection for diagnostic andinterventional procedures. ICRP Publication 113. Ann. ICRP 39(5).

32
33
34

IEC, 2010. Report 60601 Medical electrical equipment – Part 2-43: Particular requirements
for the safety of X-ray equipment for interventional procedures, 2nd ed. International
Electrotechnical Commission, Geneva, Switzerland.

35
36

IPEM, 2005. Commissioning and routine testing of mammographic X-ray systems. Report No.
89, IPEM, York.

37
38
39

Le Heron, J., 1989. Variability of medical diagnostic X-ray machine parameters as
determined from a national survey. National Radiation Laboratory Report 1989/1, (NRL,
Christchurch, New Zealand).

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4

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3

Martin, C.J., Sutton, D.G., Workmann, A., Shaw, A., Temperton, D., 1998. Protocol formeasurement of patient entrance surface dose rates for fluoroscopic equipment. Br. J.
Radiol. 71, 1283–1287.

4
5
6Martin, C.J., Sutton, D.G., 2014. Diagnostic radiology – 3 patient dosimetry. In Chapter 14,
Practical Radiation Protection in Healthcare 2nd ed., editors C.J. Martin and D.G. Sutton,
Oxford University Press: Oxford.

7
8
9

Mitchell, S.A., Martin, C.J., 2013. Comparison of ionisation and semiconductor detector
devices for measurement of the dose-width product for panoramic dental. J. Radiol. Prot.
33, 321–325.

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12

Spelic, D.C., Kaczmarek, R.V., Hilohi, M., Belella, S., 2007. United States radiological healthactivities: inspection results of mammography facilities. Biomed. Imaging Interv. J. 3,
e35. Available at http://www.biij.org/2007/2/e35

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4.

2
3
4

•

5
6

•

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8

•

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•

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•

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•

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•

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•

INTERVENTIONAL PROCEDURES

DRLs are challenging to implement for interventional procedures because
patient doses depend on a wide variety of factors in addition to patient size.
DRLs should be assessed and used as a tool for optimisation of interventional
procedures.
The Commission recommends that data for all suitable DRL quantities, if
available, be tracked for interventional procedures. This will aid in the
optimisation process.
The Commission recommends that the DRL process be applied to bothinterventional fluoroscopy and interventional CT.
For interventional procedures, complexity is a determinant of patient dose, andideally should be evaluated individually for each case. A multiplying factor for
the DRL (e.g. 2, 3 or more) may be appropriate for more complex cases of aprocedure.
An alternative method requires both a regional or national data set comprising
dosimetric data for every case of a procedure from a large number of facilities,
and a local data set of the dosimetric data for every case of the same procedure
performed at the local facility.
If the values of DRL quantities for patients are higher than expected, theinvestigation should start with evaluation of the equipment, then evaluation ofprocedure protocols, and finally evaluation of operator technique. Equipment
faults or incorrect set-up are the easiest to evaluate and correct, while operator
performance is the most difficult process to analyse and influence.	
  Cumulative fluoroscopy exposure time is a poor indicator of patient dose, but
may be recorded and used as a subsidiary DRL quantity to aid in optimisation.

29
30
31
32
33
34
35

4.1. Introduction(162)
DRLs were introduced for diagnostic radiology examinations in the 1980s andcame into wide use in the 1990s (ICRP, 1991, 2003; Wall and Shrimpton, 1998). DRLs wereoriginally developed with the underlying assumption that they are for a “standard”
examination, where the patient dose for a specific examination performed on a specificradiographic unit will vary only as a function of body part thickness (or some other measureof body mass). The DRL methodology – use of a limited number of data points to determine
median values from each facility – is predicated on this assumption.

36
37

(163)
DRLs are most useful for diagnostic examinations, such as chest radiography,
with relatively few procedural variables (NCRP, 2010). They are more challenging to28

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1
2

implement for interventional procedures, where the assumption of a ‘standard’ examination is
not valid.

3
4
5
6
7
8
9
10
11
12
13
14

(164)
For fluoroscopically guided interventional (FGI) procedures, e.g.
interventional cardiology (IC) and interventional radiology (IR) procedures, the Commission
has stated that in principle, DRLs could be used for dose management, but are difficult toimplement because of the very wide distribution of patient doses, even for instances of thesame procedure performed at the same facility (ICRP, 2007b; Padovani and Quai, 2005). The
amount of administered radiation in FGI procedures is strongly affected by procedurecomplexity due to patient anatomy, lesion characteristics and disease severity (Bernardi et al.,
2000; IAEA, 2009; Peterzol et al., 2005; Vehmas, 1997). DRLs for interventional proceduresmust be developed differently than those for other imaging modalities. However, even though
the intent of these procedures is therapeutic, not diagnostic, the Commission recommends thatthe same name (DRL) be used, as the purpose is similar—providing a tool for optimisation—and the introduction of a different name is likely to cause confusion.

15
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17
18
19
20
21
22
23
24
25

(165)
In principle, for the most accurate comparisons of dosimetric data among
populations undergoing FGI procedures, it would be desirable to normalise PKA and Ka,r databy compensating for differences in patient body habitus and weight. These affect body partthickness, which in turn affects x-ray beam attenuation [such normalisation is not necessary
for fluoroscopic time because this quantity is not related directly to body part thickness(Miller et al., 2009)]. However, a published analysis of quantities for FGI procedures, using
data from all patients regardless of weight, yields results little different from an analysis
limited to patients in the weight range of 65-85 kg (IAEA, 2009). This is consistent withprevious studies showing that the amount of administered radiation for FGI procedures isaffected much more by procedure complexity than by patient weight (IAEA, 2009; Miller etal., 2009).

26
27
28
29

(166)
The use of phantoms is not appropriate for setting DRL values for FGI, butphantoms can and should be used in evaluating equipment performance, as they provide
information essential for use in optimisation (Martin et al., 1998; Balter et al., 2011; NCRP,
2010; Vano et al., 2008, 2009b).

30

4.2. Complexity analyses(167)
Procedure complexity varies for interventional procedures because ofvariability in patints and in the lesions being treated. Patient variability refers to variability inpatient anatomy and clinical factors (e.g. body habitus, anatomic variations of the vasculartree, diameter of normal blood vessels, tendency towards arterial spasm) that determine thetechnical parameters to be used (e.g. the x-ray projections necessary to visualise different
vascular branches) and that contribute to complexity. Lesion variability refers to differencesin the pathology being treated (e.g. stenosis vs. occlusion, presence or absence of calcification,
location of a gastrointestinal bleeding site). For these reasons, interventional procedures
demonstrate substantial variability in the amount of administered radiation for individual
cases, due to patient, operator, type of materials (catheters, stents, etc.) and equipment factors

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2(Balter et al., 2004; IAEA, 2009; ICRP, 2003; Miller et al., 2003, 2012b; NCRP, 2010b; Wall,
2001).

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6
7
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9
10
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(168)
A potential approach to compensating for variability due to patient factors is toincorporate a measure of the complexity of the procedure (ICRP, 2003, 2007b). Some studies
have explored the feasibility of establishing DRL values for certain IC procedures, using
procedure complexity to normalise DRL quantities (Bernardi et al., 2000; Peterzol et al.,2005; Balter et al., 2008; IAEA, 2009). Complexity factors for PCI (number of vessels treated,
number of lesions with American College of Cardiology/American Heart Association(ACC/AHA) complexity greater than B2, number of vessels with severe tortuosity, number ofbifurcation stents) have been identified that allow these procedures to be classified as simple,
medium, or complex (Balter et al., 2008; Bernardi et al., 2000; IAEA, 2009; Ryan et al.,1988).

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(169)
Only preliminary examples of complexity analyses for other IC and IR
procedures are available. Padovani et al. (2008a) have proposed grouping radio-frequency(RF) cardiac ablation procedures performed to treat different arrhythmias: atrial fibrillation,
atrial flutter, nodal tachycardia, ventricular tachycardia and Wolff-Parkinson-White syndrome,
but the study provides estimation of DRL quantities from only a small sample of procedures.
A recent study has classified 3 levels of complexity for some common IR procedures:transjugular hepatic biopsies, biliary drainage, uterine fibroid embolisation, colon
endoprosthesis placement, femoropopliteal revascularisation, iliac stent placement and hepatic
chemoembolisation, and provides national DRL values for these procedures for Spain (Ruiz
Cruces et al., 2014).

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(170)
These examples show that it is possible to determine complexity factors forindividual IR procedures, allowing grouping into simple, medium and complex cases, and to
determine DRL values for each group. The method can be practical when a limited number offactors can explain differences in the amount of radiation that needs to be applied. For
example, in the HPA study on PCI, the number of implanted stents was identified as thedeterminant that adequately described the complexity of these procedures (Hart et al., 2007).
However, since assessing procedure complexity requires substantial clinical data that often
are not available, many recent published studies have presented DRL values for interventional
procedures without consideration of procedure complexity (Balter et al., 2008; Miller et al.,2009; Neofotistou et al., 2003; Peterzol et al., 2005; Vano et al., 2009a).

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4.3. Data sets for interventional fluoroscopy procedures(171)
A different method can be used to characterise and analyse the amount ofadministered radiation for FGI procedures, without the need for the clinical data (pathology
information and technical and clinical complexity factors) that are usually difficult to collect(Balter et al., 2011; NCRP, 2010a). It requires collection and analysis of data from a greaternumber of cases than that used to determine DRL values for diagnostic imaging (e.g.
radiography). This method requires information on the full distribution for the DRL quantities
of interest (Marshall et al., 2000). It provides a benchmark in the form of a data set that
includes the values of the DRL quantities for all of the cases of that procedure done in each of

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a large number of facilities (Balter et al., 2011; IAEA, 2009; Sánchez et al., 2011, 2014; Vanoet al., 2009a; Smans et al., 2008). This is different from the application of DRLs fordiagnostic procedures, because for diagnostic procedures, the DRL value is determined fromsummary data derived from a limited number of cases.

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(172)
When this method is used to conduct an audit, it requires both a regional or
national benchmark data set comprising dosimetric data for every case of a procedure from alarge number of facilities, sometimes referred to as an Advisory Data Set (ADS) (NCRP,
2010), and a local data set of the dosimetric data for every case of the same procedure
performed at the local facility, sometimes referred to as a Facility Data Set (Balter et al.,2011; NCRP, 2010). The method utilises data from every case of a procedure, rather than alimited sample of cases, to compensate for the large variability in the values of the DRL
quantities for these procedures (Padovani and Quai, 2005).

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(173)
Determination of the need for an investigation is the same as with other data
sets used for DRLs—the local median value is compared with the 75th percentile of thebenchmark data, and an investigation is performed if the local median exceeds the 75th
percentile of the benchmark data. The local mean value should not be used because it can bestrongly influenced by the high-dose tail of the distribution (Wall, 2001). High radiation doses
may reflect poorly functioning equipment or incorrect equipment settings, suboptimal
procedure performance, operator inexperience or high clinical complexity. An investigation
may also be desirable if the local median is below the 10th percentile (IAEA, 2009) or the
25th percentile (NCRP, 2010) of the ADS. Low radiation usage might be attributable toincomplete IC cases, inadequate image quality, or superior dose management. For better
assessment of the local data, comparison of the median, 25th and 75th percentile values of the
facility data to the corresponding percentile values of the benchmark data has been
recommended (NCRP, 2010).

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4.4. Use of multiple DRL quantities for interventional fluoroscopy(174)
The quantity used should be easily measurable (ICRP, 2007b). Cumulative
fluoroscopy time is readily available, but has been shown to correlate poorly with Dskin,max(Fletcher et al., 2002). For fluoroscopically guided procedures, Ka,r and PKA have beendeveloped as estimators of the risk of radiation-related tissue reactions and stochastic effects,
respectively.

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(175)
PKA is a surrogate measure of the amount of energy delivered to the patient,and thus a reasonable indicator of the risk of stochastic effects (Chambers et al., 2011;
Hirshfeld et al., 2004; Miller et al., 2003, 2012a; NCRP, 2010). Ka,r is a useful predictor of
Dskin,max, and therefore of the risk of tissue reactions, such as radiation-induced skin injury(Chambers et al., 2011; Hirshfeld et al., 2004; Miller et al., 2012a; NCRP, 2010; Jones et al.,2014).

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(176)
In Europe, PKA is commonly used. In the U.S., Ka,r is more available, likely
because the U.S. Food and Drug Administration has required that all fluoroscopic units
manufactured after mid-2006 display reference air kerma, but has not required display of PKA.
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Display of both Ka,r and PKA on interventional fluoroscopy systems is also required forcompliance with the standards of the International Electrotechnical Commission (IEC, 2000,
2010). For purposes of comparison to DRLs, both quantities are acceptable (ICRP, 2007b;
NCRP, 2010).

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(177)
Several authors have proposed DRL values for FGI procedures using multiple
quantities: PKA, Ka,r, fluoroscopy time and number of acquired images (Miller et al., 2009,2012b; Vañó and Gonzalez, 2001). This approach helps identify the cause when radiation use
is not optimised. For example, if PKA exceeds the DRL value, but Ka,r is within an acceptable
range, there may be insufficient attention to collimation. Also, if the median PKA and/or Ka,rin a particular institution exceeds the corresponding DRL value, evaluation of fluoroscopy
time and the number of acquired images may help determine whether these are contributing
factors. The Commission recommends that data for all suitable DRL quantities that areavailable be tracked for interventional procedures at facilities where these procedures are
performed.

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(178)
If the median values of the DRL quantities are higher than expected,
investigation of the fluoroscopic equipment is appropriate. Phantoms made from PMMA slabs
that simulate patients provide an excellent method for evaluating equipment performance interms of Ka,e and air kerma rate. They can provide assessments of radiation levels fromdifferent imaging programmes, information that is essential for optimisation (Martin et al.,
1998; Ubeda et al., 2011; Padovani et al., 2008b; Vano et al., 2005). If the fluoroscopic
equipment is functioning properly and within specification, procedure protocols and operator
technique should be examined (NRPB, 1990; NCRP, 2010; Vañó and Gonzalez, 2001; Wall,
2001). This sequence has been recommended because equipment faults or incorrect set-up are
the easiest to evaluate and correct, while operator performance is the most difficult process toanalyse and influence (Balter et al., 2011; Vañó and Gonzalez, 2001).

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(179)
Cone-beam CT (CBCT) has become a routine part of some interventional
fluoroscopy procedures. Optimisation of this portion of the procedure has therefore become
important. Recording PKA and Ka,r for the CBCT portion of interventional procedures, when
this information is available, may be helpful in optimisation of this portion of interventional
procedures (Section 5.3.3).

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4.5. Interventional CT(180)
Interventions can be performed with CT guidance. Relatively little data are
available on the number of procedures performed or on temporal trends, but it is clear that the
numbers and types of procedures are increasing. For example, the percentage of image-guided
percutaneous lung biopsies performed with CT guidance (as opposed to fluoroscopy
guidance) at the Mayo Clinic in the U.S. increased from 66% in 1996-1998 to 98% in 20032005 (Minot et al., 2012). CT is used primarily to guide biopsy of small or deep lesions in thechest, abdomen and pelvis that are not seen well with ultrasound or fluoroscopy. CT provides
high-resolution images and the ability to visualise bowel and bone.

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(181)
CT-guided interventions can be performed by using intermittent CT scans
performed while the physician steps out of the scanner room, or by using CT fluoroscopy(physician-controlled real-time intermittent or continuous CT exposure during needle ordevice manipulation). CT fluoroscopy is a CT imaging method, not a fluoroscopic imaging
method. CT fluoroscopy facilitates CT-guided biopsy procedures by allowing visualisation of
the needle trajectory from skin entry to the target point. The principal advantage of CT
fluoroscopy over standard CT guidance is the ability to use real-time monitoring to accesslesions that move within the body as a result of patient breathing or other motion. Its use canpermit procedures to be performed more rapidly and efficiently (Gianfelice et al., 2000b), and
it is therefore increasingly popular.

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(182)
CT fluoroscopy is applicable to a wide variety of non-vascular interventions(Daly and Templeton, 1999). It is used for needle guidance during drainage of fluid
collections, spinal pain management procedures, tumour ablation and percutaneous needle
biopsy in the chest, spine, abdomen and pelvis (Buls et al., 2003; Hoang et al., 2011; Joemai
et al., 2009; Trumm et al., 2012). Unfortunately, CT fluoroscopy results in relatively highradiation doses to both the patient and the physician operator, and there is a steep learning
curve (Gianfelice et al., 2000a; Kim et al., 2011; Saidatul et al., 2010).

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(183)
Variability in patient dose from CT-guided interventions is dominated byprocedure complexity, not patient size. In centres where a large number of these proceduresare performed, it is recommended that the values for DRL quantities be analysed according to
the framework described for setting DRLs for interventional fluoroscopy procedures. Similar
methods for application of the DRL process (complexity analysis and evaluation of allprocedures performed) are likely to be useful. Unfortunately, complexity factors for CTguided procedures have not been established, and there are few data from which to establish
DRL values. As with interventional fluoroscopy, the Commission recommends that DRLs be
established for all quantities that are available: CTDIvol, DLP, the number of CT sequences
obtained, and CT fluoroscopy time.

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4.6. References

29
30
31
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AAPM, 2011. AAPM recommendations regarding notification and alert values for CT
scanners: Guidelines for use of the NEMA XR 25 CT dose-check standard. American
Association of Physicists in Medicine, p. AAPM Dose Check Guidelines version 1.0
4/27/2011.

33
34
35
36
37

Balter, S., Miller, D.L., Schueler, B.A., Cole, P.E., Berenstein, A., Albert, R., Georgia, J.D.,
Noonan, P.T., Russell, E.J., Malisch, T.W., Vogelzang, R.L., Geisinger, M., Cardella, J.F.,
St George, J., Miller, G.L., III, Anderson, J., 2004. Radiation doses in interventional
radiology procedures: The RAD-IR study. Part III. Dosimetric performance of thefluoroscopes. J. Vasc. Interv. Radiol. 15, 919–926.

38
39

Balter, S., Miller, D.L., Vano, E., Ortiz Lopez, P., Bernardi, G., Cotelo, E., Faulkner, K.,
Nowotny, R., Padovani, R., Ramirez, A., 2008. A pilot study exploring the possibility of71

DRAFT REPORT FOR CONSULTATION: DO NOT REFERENCE

1
2

establishing guidance levels in x-ray directed interventional procedures. Med. Phys. 35,
673–680.

3
4

Balter, S., Rosenstein, M., Miller, D.L., Schueler, B., Spelic, D., 2011. Patient radiation dose
audits for fluoroscopically guided interventional procedures. Med. Phys. 38, 1611–1618.

5
6
7
8

Bernardi, G., Padovani, R., Morocutti, G., Vano, E., Malisan, M.R., Rinuncini, M., Spedicato,
L., Fioretti, P.M., 2000. Clinical and technical determinants of the complexity of
percutaneous transluminal coronary angioplasty procedures: analysis in relation toradiation exposure parameters. Catheter. Cardiovasc. Interv. 51, 1–9; discussion 10.

910

Bor, D., Olğar, T., Toklu, T., Cağlan, A., Onal, E., Padovani, R., 2009. Patient doses anddosimetric evaluations in interventional cardiology. Phys Med. 25, 31–42.

11
12

Buls, N., Pagés, J., de Mey, J., Osteaux, M., 2003. Evaluation of patient and staff doses
during various CT fluoroscopy guided interventions. Health Phys. 85, 165–173.

13
14
15

Chambers, C.E., Fetterly, K.A., Holzer, R., Paul Lin, P.-J., Blankenship, J.C., Balter, S.,
Laskey, W.K., 2011. Radiation safety program for the cardiac catheterization laboratory.
Catheter. Cardiovasc. Interv. 77, 546–556.

16
17

CRCPD/CDRH, 1992. Average Patient Exposure Guides—1992. CRCPD Pub. 92–4.
Conference of Radiation Control Program Directors, Frankfort, KY.

18
19

Daly, B., Templeton, P.A., 1999. Real-time CT fluoroscopy: evolution of an interventional
tool. Radiology 211, 309–315.

20
21
22
23
24

EC, Council Directive 2013/59/Euratom of 5 December 2013 laying down basic safety
standards for protection against the dangers arising from exposure to ionising radiation,and repealing Directives 89/618/Euratom, 90/641/Euratom, 96/29/Euratom,
97/43/Euratom and 2003/122/Euratom. Off. J. Eur. Commun. L13; 57, 1–73 (17 Jan
2014).

25
26
27

EC, 1997. Council Directive 97/43/Euratom of 30 June 1997 on health protection ofindividuals against the dangers of ionising radiation in relation to medical exposure. Off.
J. Eur. Commun. L180, 22–27.

28
29
30

Faulkner, K., Ortiz-Lopez, P., Vano, E., 2005. Patient dosimetry in diagnostic andinterventional radiology: a practical approach using trigger levels. Radiat. Prot. Dosim.
117, 166–168.

31
32
33

FDA, 1984. Nationwide Evaluation of X-Ray Trends (NEXT) eight years of data (1974-1981).
U.S. Department of Health and Human Services, Public Health Service, Food and Drug
Administration.

34
35
36
37
38

FDA, 1994. Important information for physicians and other health care professionals:
avoidance of serious x-ray-induced skin injuries to patients during fluoroscopicallyguided
procedures,
availableat:
http://www.fda.gov/downloads/radiationemittingproducts/radiationemittingproductsandprocedures/medicalimaging/medicalxrays/ucm116677.pdf.

72

DRAFT REPORT FOR CONSULTATION: DO NOT REFERENCE

1
2
3
4

FDA, 2004. FDA public health advisory: avoidance of serious x-ray-induced skin injuries topatients
duringfluoroscopicallyguided
procedures,
availableat:
http://www.fda.gov/medicaldevices/safety/alertsandnotices/publichealthnotifications/ucm
063084.htm.

5
6
7
8

FDA, 2005. Recording information in the patient’s medical that identifies the potential forserious x-ray-induced skin injuries, available at: http://www.fda.gov/radiationemittingproducts/radiationemittingproductsandprocedures/medicalimaging/medicalxrays/ucm117030.htm.

9
10
11

Fletcher, D.W., Miller, D.L., Balter, S., Taylor, M.A., 2002. Comparison of four techniques toestimate radiation dose to skin during angiographic and interventional radiology
procedures. J. Vasc. Interv. Radiol. 13, 391–397.

12
13
14

Gianfelice, D., Lepanto, L., Perreault, P., Chartrand-Lefebvre, C., Milette, P.C., 2000a. Effectof the learning process on procedure times and radiation exposure for CT fluoroscopyguided percutaneous biopsy procedures. J. Vasc. Interv. Radiol. 11, 1217–1221.

15
16
17

Gianfelice, D., Lepanto, L., Perreault, P., Chartrand-Lefebvre, C., Milette, P.C., 2000b. Valueof CT fluoroscopy for percutaneous biopsy procedures. J. Vasc. Interv. Radiol. 11, 879–
884.

18
19
20

Hart, D., Hillier, M.C., Wall, B.F., 2007. Doses to patients from common radiographic, andfluoroscopic X-ray imaging procedures in the UK – 2005 review. Report HPA-RPD-029.
HPA, Chilton.

21
22

Hart, D., Hillier, M.C., Wall, B.F., 2009. National reference doses for common radiographic,
fluoroscopic and dental X-ray examinations in the UK. Br. J. Radiol. 82, 1–12.

23
24
25
26
27
28

Hesse, B., Tagil, K., Cuocolo, A., Anagnostopoulos, C., Bardies, M., Bax, J., Bengel, F.,
Busemann Sokole, E., Davies, G., Dondi, M., Edenbrandt, L., Franken, P., Kjaer, A.,
Knuuti, J., Lassmann, M., Ljungberg, M., Marcassa, C., Marie, P.Y., McKiddie, F.,
O'Connor, M., Prulovich, E., Underwood, R., van Eck-Smit, B., 2005. EANM/ESC
procedural guidelines for myocardial perfusion imaging in nuclear cardiology. Eur. J.
Nucl. Med. Mol. Imaging 32, 855–897.

29
30
31
32
33
34
35

Hirshfeld, J.W., Jr., Balter, S., Brinker, J.A., Kern, M.J., Klein, L.W., Lindsay, B.D.,
Tommaso, C.L., Tracy, C.M., Wagner, L.K., 2004. ACCF/AHA/HRS/SCAI clinicalcompetence statement on physician knowledge to optimize patient safety and image
quality in fluoroscopically guided invasive cardiovascular procedures: a report of theAmerican College of Cardiology Foundation/American Heart Association/American
College of Physicians Task Force on Clinical Competence and Training. J. Am. Coll.
Cardiol. 44, 2259–2282.

36
37
38
39

Hoang, J.K., Yoshizumi, T.T., Toncheva, G., Gray, L., Gafton, A.R., Huh, B.K., Eastwood,
J.D., Lascola, C.D., Hurwitz, L.M., 2011. Radiation dose exposure for lumbar spine
epidural steroid injections: a comparison of conventional fluoroscopy data and CT
fluoroscopy techniques. AJR Am. J. Roentgenol. 197, 778–782.

73

DRAFT REPORT FOR CONSULTATION: DO NOT REFERENCE

1
2
3

IAEA, 1996. International basic safety standards for protection against ionizing radiation andthe safety of radiation sources. Safety Series No. 115. International Atomic Energy
Agency, Vienna.

4
5
6

IAEA, 2009. Establishing guidance levels in x ray guided medical interventional procedures:
A pilot study. Safety Reports Series No. 59. International Atomic Energy Agency,
Vienna.

7
8

ICRP, 1991. 1990 Recommendations of the International Commission on RadiologicalProtection. ICRP Publication 60. Ann. ICRP 21(1–3).

9
10

ICRP, 1996. Radiological protection and safety in medicine. ICRP Publication 73. Ann. ICRP
26(2).

11
12

ICRP, 2001. Radiation and your patient: a guide for medical practitioners. Supporting
Guidance 2. Ann. ICRP 31(4).

13
14

ICRP, 2003. Diagnostic reference levels in medical imaging: review and additional advice.
ICRP online educational reference.

15
16

ICRP, 2007a. The 2007 Recommendations of the International Commission on RadiologicalProtection. ICRP publication 103. Ann. ICRP 37(2–4).

17

ICRP, 2007b. Radiological protection in medicine. ICRP Publication 105. Ann. ICRP 37(6).

18
19

ICRU, 2005. Patient dosimetry for X rays used in medical imaging. Report 74. Journal of the
ICRU 5, 1–113.

20
21
22

IEC, 2000. Report 60601 Medical electrical equipment - Part 2-43: Particular requirements
for the safety of X-ray equipment for interventional procedures. International
Electrotechnical Commission, Geneva, Switzerland.

23
24
25

IEC, 2010. Report 60601 Medical electrical equipment - Part 2-43: Particular requirements
for the safety of X-ray equipment for interventional procedures, 2nd ed. International
Electrotechnical Commission, Geneva, Switzerland.

26
27

Jensen, J.E., Butler, P.F., 1978. Breast exposure: nationwide trends; a mammographic quality
assurance program –results to date. Radiol. Technol. 50, 251–257.

28
29

Jones, A.K., Ensor, J.E., Pasciak, A.S., 2014. How accurately can the peak skin dose influoroscopy be determined using indirect dose metrics? Med. Phys. 41, 071913.

30
31
32

Joemai, R.M., Zweers, D., Obermann, W.R., Geleijns, J., 2009. Assessment of patient andoccupational dose in established and new applications of MDCT fluoroscopy. Am. J.
Roentgenol. 192, 881–886.

33
34

Marshall, N.W., Chapple, C.L., Kotre, C.J., 2000. Diagnostic reference levels ininterventional radiology. Phys. Med. Biol. 45, 3833–3846.

35
36
37

Martin, C.J., Sutton, D.G., Workmann, A., Shaw, A., Temperton, D., 1998. Protocol formeasurement of patient entrance surface dose rates for fluoroscopic equipment. Br. J.
Radiol. 71, 1283–1287.

74

DRAFT REPORT FOR CONSULTATION: DO NOT REFERENCE

1
2
3
4
5

Miller, D.L., Balter, S., Cole, P.E., Lu, H.T., Schueler, B.A., Geisinger, M., Berenstein, A.,
Albert, R., Georgia, J.D., Noonan, P.T., St George, J., Cardella, J.F., Russell, E., Malisch,T., Vogelzang, R.L., Miller, G., Anderson, J., 2003. Radiation doses in interventional
radiology procedures: The RAD-IR study Part I. Overall measures of dose. J. Vasc. Interv.
Radiol. 14, 711–727.

6
7
8
9

Miller, D.L., Balter, S., Dixon, R.G., Nikolic, B., Bartal, G., Cardella, J.F., Dauer, L.T.,
Stecker, M.S., 2012a. Quality improvement guidelines for recording patient radiationdose in the medical record for fluoroscopically guided procedures. J. Vasc. Interv. Radiol.
23, 11–18.

10
11
12

Miller, D.L., Hilohi, C.M., Spelic, D.C., 2012b. Patient radiation doses in interventional
cardiology in the U.S.: Advisory data sets and possible initial values for U.S. reference
levels. Med. Phys. 39, 6276–6286.

13
14
15

Miller, D.L., Kwon, D., Bonavia, G.H., 2009. Reference levels for patient radiation doses ininterventional radiology: proposed initial values for U.S. practice. Radiology 253, 753–
764.

16
17
18

NRPB, 1990. Patient dose reduction in diagnostic radiology: Report by the Royal College ofRadiologists and the National Radiological Protection Board. National Radiation
Protection Board, London.

19
20
21

NCRP, 2010. Radiation dose management for fluoroscopically guided interventional medical
procedures.
Report No. 168. National Council on Radiation Protection andMeasurements, Bethesda, MD.

22
23
24

NCRP, 2012. Reference levels and achievable doses in medical and dental imaging:recommendations for the United States. NCRP Report No. 172. National Council on
Radiation Protection and Measurements, Bethesda, MD.

25
26

NEMA, 2010. Computed tomography dose check. NEMA Standards Publication XR 25-2010.
National Electrical Manufacturers Association, Rosslyn, Virginia.

27
28
29

Neofotistou, V., Vano, E., Padovani, R., Kotre, J., Dowling, A., Toivonen, M., Kottou, S.,
Tsapaki, V., Willis, S., Bernardi, G., Faulkner, K., 2003. Preliminary reference levels ininterventional cardiology. Eur. Radiol. 13, 2259–2263.

30
31
32

NRPB, 1999. Guidelines on patient dose to promote the optimisation of protection for
diagnostic medical exposures. Documents of the NRPB 10(1). National RadiologicalProtection Board, Chilton.

33
34

NRPB/RCR, 1990. Patient dose reduction in diagnostic radiology. Documents of the NRPB
1(3). HMSO, London.

35
36

Padovani, R., Quai, E., 2005. Patient dosimetry approaches in interventional cardiology andliterature dose data review. Radiat. Prot. Dosim. 117, 217–221.

37
38

Padovani, R., Vano, E., Trianni, A., Bokou, C., Bosmans, H., Bor, D., Jankowski, J., Torbica,P., Kepler, K., Dowling, A., Milu, C., Tsapaki, V., Salat, D., Vassileva, J., Faulkner, K.,

75

DRAFT REPORT FOR CONSULTATION: DO NOT REFERENCE

1
2

2008a. Reference levels at European level for cardiac interventional procedures. Radiat.
Prot. Dosim. 129, 104–107.

3
4
5

Padovani, R., Trianni, A., Bokou, C., Bosmans, H., Jankowski, J., Kottou, S., Kepler, K.,
Malone, J., Tsapaki, V., Salat, D., Vano, E., Vassileva, J., 2008b. Survey on performanceassessment of cardiac angiography systems. Radiat. Prot. Dosim. 129, 108–111.

6
7

Peterzol, A., Quai, E., Padovani, R., Bernardi, G., Kotre, C.J., Dowling, A., 2005. Reference
levels in PTCA as a function of procedure complexity. Radiat. Prot. Dosim. 117, 54–58.

8
9
10
11
12
13

Ruiz Cruces, R., Vañó, E., Carrera, F., Hernández-Armas, J., Canis, M., Soler, M.D.M.,
Moreno, F., Pérez-Martinez, M., Sánchez-Casanueva, R.M., 2014. Diagnostic Reference
Levels and Complexity Indices in Interventional Radiology. A National Programme.
[poster]
ECR
2014.
Availableat
http://posterng.netkey.at/esr/viewing/index.php?module=viewing_poster&doi=10.1594/e
cr2014/C-0846. Accessed June 4, 2015.

14
15
16
17
18
19

Ryan, T.J., Faxon, D.P., Gunnar, R.M., Kennedy, J.W., King, S.B., 3rd, Loop, F.D., Peterson,
K.L., Reeves, T.J., Williams, D.O., Winters, W.L., Jr., et al., 1988. Guidelines for
percutaneous transluminal coronary angioplasty. A report of the American College of
Cardiology/American Heart Association Task Force on Assessment of Diagnostic andTherapeutic Cardiovascular Procedures (Subcommittee on Percutaneous Transluminal
Coronary Angioplasty). Circulation 78, 486–502.

20
21
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Samara, E.T., Aroua, A., De, P.R., Stauffer, J.C., Schmidt, S., Trueb, P.R., Stuessi, A., Treier,R., Bochud, F., Verdun, F.R., 2012. An audit of diagnostic reference levels ininterventional cardiology and radiology: are there differences between academic and nonacademic centres? Radiat. Prot. Dosim. 148, 74–82.

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Sánchez, R.M., Vano, E., Fernández, J.M., Escaned, J., Goicolea, J., Pifarré, X; DOCCACI
Group, 2014. Initial results from a national follow-up program to monitor radiation doses
for patients in interventional cardiology. Rev. Esp. Cardiol. 67, 63–65.

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Sánchez, R., Vano, E., Fernández, J.M., Sotil, J., Carrera, F., Armas, J., Rosales, F., Pifarre,
X., Escaned, J., Angel, J., Diaz, J.F., Bosa, F., Saez, J.R., Goicolea, J., 2011. A national
programme for patient and staff dose monitoring in interventional cardiology. Radiat.
Prot. Dosim. 147, 57–61.

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Shrimpton, P.C., Wall, B.F., Jones, D.G., Fisher, E.S., Hillier, M.C., Kendall, G.M., Harrison,
R.M., 1986. A national survey of doses to patients undergoing a selection of routine x-ray
examinations in English hospitals. NRPB-R200. HMSO, London.

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Smans, K., Vaño, E., Sanchez, R., Schultz, F.W., Zoetelief, J., Kiljunen, T., Maccia, C.,
Järvinen, H., Bly, R., Kosunen, A., Faulkner, K., Bosmans, H., 2008. Results of aEuropean survey on patient doses in paediatric radiology. Radiat. Prot. Dosim. 129, 204–
210.

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Tsapaki, V., Ahmed, N.A., AlSuwaidi, J.S., Beganovic, A., Benider, A., BenOmrane, L.,
Borisova, R., Economides, S., El-Nachef, L., Faj, D., Hovhannesyan, A., Kharita, M.H.,

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Khelassi-Toutaoui, N., Manatrakul, N., Mirsaidov, I., Shaaban, M., Ursulean, I.,
Wambani, J.S., Zaman, A., Ziliukas, J., Zontar, D., Rehani, M.M., 2009. Radiation
exposure to patients during interventional procedures in 20 countries: initial IAEA project
results. AJR. Am. J. Roentgenol. 193, 559–569.

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Trianni, A., Gasparini, D., Padovani, R., 2011. Trigger Levels to prevent tissue reaction ininterventional radiology procedures. Standards, applications and quality assurance in
medical radiation dosimetry (IDOS), IAEA, vol 2, 115–124.

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Ubeda, C., Vano, E., Miranda, P., Leyton, F., Martinez, L.C., Oyarzun, C., 2011. Radiationdose and image quality for paediatric interventional cardiology systems. A national
survey in Chile. Radiat. Prot. Dosim. 147, 429–438.

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Vañó, E., Gonzalez, L., 2001. Approaches to establishing reference levels in interventional
radiology. Radiat. Prot. Dosim. 94, 109–112.

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Vano, E., Geiger, B., Schreiner, A., Back, C., Beissel, J., 2005. Dynamic flat panel detector
versus image intensifier in cardiac imaging: dose and image quality. Phys. Med. Biol. 50,
5731–5342.

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Vano, E., Ubeda, C., Leyton, F., Miranda, P., 2008. Radiation dose and image quality for
paediatric interventional cardiology. Phys. Med. Biol. 53, 4049–4062.

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Vano, E., Sanchez, R., Fernandez, J.M., Gallego, J.J., Verdu, J.F., de Garay, M.G., Azpiazu,
A., Segarra, A., Hernandez, M.T., Canis, M., Diaz, F., Moreno, F., Palmero, J., 2009a.
Patient dose reference levels for interventional radiology: a national approach.
Cardiovasc. Intervent. Radiol. 32, 19–24.

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Vano, E., Sanchez, R., Fernandez, J.M., Rosales, F., Garcia, M.A., Sotil, J., Hernandez, J.,
Carrera, F., Ciudad, J., Soler, M.M., Ballester, T., 2009b. Importance of dose settings inthe x-ray systems used for interventional radiology: a national survey. Cardiovasc.
Intervent. Radiol. 32, 121–126.

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Vehmas, T., 1997. Radiation exposure during standard and complex interventional procedures.
Br. J. Radiol. 70, 296–298.

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Verdun, F.R., Aroua, A., Trueb, P.R., Vock, P., Valley, J.F., 2005. Diagnostic andinterventional radiology: a strategy to introduce reference dose level taking into accountthe national practice. Radiat. Prot. Dosim. 114, 188–191.

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Wall, B.F., 2001. Diagnostic reference levels –the way forward. Br. J. Radiol. 74, 785–788.

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Wall, B.F., Shrimpton, P.C., 1998. The historical development of reference doses indiagnostic radiology. Radiat. Prot. Dosim. 80, 15–19.

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5.

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DIGITAL RADIOGRAPHY, CT, NUCLEAR MEDICINE, AND
MULTIMODALITY PROCEDURES

The general points mentioned in Chapter 2 apply to all modalities unless otherwise
specified.
DRLs developed for advanced digital radiographic techniques (e.g. tomosynthesis,
dual-energy subtraction, contrast-enhanced subtraction, cone-beam CT) need to take
into account the ‘multiple image’ aspect of the technique and should distinguishthese procedures from more standard procedures.
CT utilises CTDIvol and DLP as DRL quantities. The number of scan sequences inthe examination may be helpful as well. Size-specific dose estimates (SSDE) may be
used as an additional step for optimisation.
For CT, the DLP value used is the cumulative DLP for the entire examination. The
CTDIvol value used is the displayed CTDIvol for each sequence. DLP values forindividual scan sequences can be useful as well, and may be used in addition to the
cumulative DLP.
For nuclear medicine, the Commission recommends that DRL values be establishedin terms of the administered activity per kg body weight of a specific radionuclide
for a specific clinical task and, if relevant, the radiopharmaceutical used.
Weight-based administered activities may not be appropriate for examinations
where the radiopharmaceutical is concentrated predominantly in a single organ (e.g.
thyroid scans, lung perfusion scans).
The administered activity for examinations of individual patients may be adjusted
upwards when there are sound clinical reasons. Setting of a fixed maximum activity
for very obese patients may also be considered.
Since DRLs for nuclear medicine procedures and CT procedures apply to radiationfrom very different modalities, and use different DRL quantities, it is appropriate to
set and present DRL values for each modality independently.

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5.1. Digital radiography detectors(184)
For the purpose of this report, digital radiography refers to the planar imagingof patients utilising either direct or indirect digital detector systems, including digital
mammography. It also includes advanced imaging techniques such as tomosynthesis. Digitaldetectors include the following: storage-phosphor techniques (often referred to as ‘computed
radiography’); charge-coupled device (CCD) based detectors; flat-panel detectors with direct
or indirect conversion; and photon counting detectors. Mammography is discussed separately
in Chapter 3.

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(185)
Storage-phosphor was the first available technique for digital radiography.
Since storage plates are exposed in cassettes with standard dimensions, no change ofgenerator, x-ray tube, or wall- or table-mounted Bucky system is necessary. Bedside,

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examinations and other special projections are possible. In general, there is no connection
between the generator and the reader that processes the storage-phosphor plate post-exposure.
The generator settings employed for the exposure determine the patient exposure. The reader
only senses the signal received by the detector. The disconnect between generator settings anddetector signal has a bearing on suitable quantities for DRLs for these systems.

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(186)
CCD systems represent a small share of the market in most countries. The
image of a luminescent screen is recorded with CCD cameras and converted into digital
images.

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(187)
More recently, flat-panel detectors have gained a large share of the market.
They utilise direct or indirect conversion of x rays into electrical signals. These detectors
provide high quantum efficiency, excellent image quality, and enable a substantial reduction
in patient dose. Portable and wireless versions of these detectors have enabled a broad rangeof examinations to be performed in all healthcare settings.

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(188)
The most recent type of detector to gain market share is the photon-counting
detector. These detectors use photon counting as opposed to the energy integration used by
the other detector types. They demonstrate excellent efficiency and also allow the introductionof advanced image processing techniques such as tissue discrimination. They are currently
used for mammography, and are being introduced for CT and digital radiography.

195.2. DRLs in digital radiography

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(189)
All digital detector systems have a high dynamic range. Due to the direct
relationship between the dose received by the detector (and consequently patient dose) andimage quality, high doses provide high image quality without the saturation seen in filmbased imaging techniques. The absence of deterioration of image quality at high doses meansthat QA and audit programmes are needed to ensure patient dose is optimised to the clinicaltask and that ‘dose creep’ (use of unnecessarily high levels of radiation) (Williams et al.,2007; ICRP, 2004) does not occur. Application of DRLs is an essential part of a QA system.
Also, as digital detectors are often more sensitive than the film-based systems they are
replacing, DRLs should be set explicitly for digital detectors (not copied from film
techniques) whenever digital detectors are installed.

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(190)
In Chapter 2 of Publication 93 (ICRP, 2004), the issues described above are
expanded upon with specific recommendations concerning the transition from screen-film
radiography to digital radiography, including the recommendation that digital radiographyspecific DRLs be developed. The pitfalls of dose creep are explained in greater detail.

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(191)
DRLs for digital radiography should be set taking into account the principles
set out in this report. In collecting patient data on DRL quantities for digital radiography, it isimportant to know the detector type used so that the data may be analysed by detector type, as
the values of the DRL quantities for specific examinations may vary by detector type due to79

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sensitivity differences. In some cases, it may be worth considering establishing different DRL
values for flat-panel detectors and storage-phosphor detectors, even for the same procedure.

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5.2.1. DRL quantities(192)
The specific DRL quantity to be utilised in the development of DRLs for
digital radiography will be determined by the type of digital imaging system and technicalconsiderations. Recommendations are provided in Chapter 2. The choice of quantity should
also take into account the DRL quantity used in other literature and DRL values.

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(193)
The quantities used to define DRL values for digital radiography depend upon
the digital detector system in question, but include PKA and Ka,e. Use of both PKA and either
Ka,e or Ka,i is recommended, if available. PKA may be recorded automatically if theradiography system has the capability to measure or calculate it, so users can compare thesedata with DRL values directly. There is much historical data available for Ka,e, but
assessment involves either calculation or labour intensive measurements and so assessment
may not always be possible. Where routine QC tube output data or direct measurement
capabilities are not available to calculate Ka,e, standard output data may be used (Asada et al.,2014).

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(194)
For projection radiography, the Commission recommends using two quantities
to set DRLs: PKA and either Ka,e or Ka,i in order to simplify evaluation of the proper use ofcollimation.

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5.2.2. Procedure selection(195)
With the advances in image processing made available by the implementationof digital imaging, many advanced radiographic techniques are becoming available. Examplesof these include tomosynthesis, dual-energy subtraction, and contrast-enhanced subtraction.
These advanced techniques have in common the use of multiple low-dose radiographs as
input to advanced image-processing software that produces final images with added
information, such as tissue discrimination or cross-sectional ‘slices’. Therefore, any DRL
developed for these techniques needs to take into account the ‘multiple image’ aspect andshould distinguish these procedures from more standard procedures. For example, DRL
values will differ between breast tomosynthesis and a standard two-view craniocaudal andmediolateral oblique mammogram.

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5.3. Computed Tomography

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5.3.1. DRLs in CT

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(196)
There are many examples in the literature of DRLs values established for CT(ICRP, 2007; NCRP, 2012; Foley et al., 2012). For the purpose of this report, the term ‘CT’applies to both single and multi-detector CT scanners.

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(197)
CT procedures deliver approximately 50% of the collective effective dose frommedical and dental exposures in many countries, due to the relatively high-dose nature of CT
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procedures compared to other diagnostic imaging modalities (NCRP, 2009). This contributionis also increasing. For instance, in the U.K., the contribution of CT to the collective effective
dose from medical and dental exposures has risen to 68% (HPA, 2010).

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(198)
All CT digital detector systems have a high dynamic range. Coupled with thedirect relationship between dose to the detector (and consequently patient dose) and image
quality, this means that high doses will provide high image quality without the saturation seenin film-based imaging techniques. This means that, as with digital radiography, QA and audit
programmes are essential to ensure that patient dose is optimised for the clinical task. DRLs
are an essential tool within such a QA programme.

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(199)
It is important that the data set in patient surveys for developing DRL values
for CT includes detector technology, detector configuration, and the image reconstruction
algorithm, so that differences between detector types and reconstruction algorithms are
identified correctly. It may be useful to develop different DRL values locally for different CT
technologies (e.g. single slice vs. multi-slice scanners, filtered back projection vs. iterative
reconstruction), even for the same procedure.

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5.3.2. Considerations for DRL surveys in CT

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(200)
DRL values for CT should be set taking into account the principles set out inthis report. There are specific issues that must be decided prior to surveying DRL quantities
and setting DRL values for CT.

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(201)
Patient selection is an important aspect of setting DRLs. In CT, as in otherimaging modalities, patient size plays a significant role in the determination of the required
amount of radiation to achieve adequate image quality for a given procedure (Samei andChristianson, 2014). The choice is either to set a patient thickness range (often stipulated as aweight range), or to utilise large-scale electronic patient data from radiology information
systems or PACS systems. With a reduced range in patient size, variation in DRL quantities isreduced substantially. As a result, data from fewer patients are required for the determinationof DRL values (IPEM, 2004).

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(202)
Another important aspect of setting DRLs is the choice of quantity. The
options include CTDI as either CTDIw or CTDIvol, and DLP. CTDI is defined and explained
in detail in Publication 102 (ICRP, 2007). DLP is a quantity that utilises both CTDI and thescan length for a given patient. It therefore also includes operator issues that are important toconsider when setting DRLs for CT, as they reflect practice on real patients. Both of these
metrics reflect the amount of ionising radiation applied to perform the medical imaging task
and are indicative of the scanner settings employed within the CT protocol. They are usefulmetrics for optimisation.

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(203)
The precise quantity to be utilised in the development of DRLs will be
determined by the organisation setting the DRL. However, it would be prudent to takeaccount of the quantities used in other literature and published DRL values. Where possible,

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the Commission recommends that both CTDIvol and DLP be assessed in patient surveys
performed for the purpose of setting DRL values, as is the practice in France and the U.K.
(Roch and Aubert, 2013, Shrimpton et al., 2014). Modern CT scanners permit determinationof effective diameter or patient equivalent thickness. This should be considered as anadditional refinement for setting paediatric DRL values (Chapter 6). Size-specific dose
estimates (SSDE) may be used in addition to the recommended DRL quantities as anadditional source of information for optimisation.

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(204)
When optimisation is performed for CT, it is necessary to consider both theexamination as a whole (all scan sequences) and each sequence (e.g. non-contrast-enhanced,
contrast-enhanced, delayed) individually. The DLP quantity used is the cumulative DLP forthe entire examination, as this gives a good representation of the total amount of ionisingradiation applied during the examination. DLP values for individual scan sequences can be ofvalue as well, and may be used in addition to the cumulative DLP.

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(205)
Use of tube current modulation can reduce patient dose by 30%-40% per scan,and has therefore been adopted widely. However, CTDIvol in an individual scan is notconstant when tube current modulation is used. In this setting, the displayed CTDIvol after thescan sequence has been performed is usually the average CTDIvol over the length of the scan.
The displayed CTDIvol should be recorded for each scan sequence, as it is often different foreach scan sequence. However, users should check that the CTDIvol value recorded
corresponds to what they think it is, since some manufacturers have used other values such as
the maximum CTDIvol during a scan. It can also be helpful to record the number of scansequences for the examination, as this may also help explain differences in cumulative DLP.

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(206)
This approach has the advantage of simplifying certain aspects of the
optimisation analysis. For example, if, in local practice, the median cumulative DLP exceeds
the DRL value, but the median CTDIvol for each scan sequence does not, this suggests that
attention should be directed at scan length and the number of scan sequences.

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(207)
Procedure selection is also important in ensuring that DRLs are fit-for-purpose.
There are two aspects to this. It is important when developing DRLs that all of the dosimetricdata collected comes from similar procedures across all participating clinical facilities. This
ensures that comparisons between facilities remain valid and useful. A common problem isthat typically there is no standard for describing or naming examination types acrossfacilities—the same examination (e.g. an adult CT scan of the head without intravenous
contrast material) is often named differently at different facilities (Morin et al., 2011).

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(208)
It may also be important to specify in detail both the clinical task associatedwith the procedure and the body region scanned, as differences between similar procedures
may affect patient dose and hence DRL values. Scans of the kidney for kidney stones, forinstance, may employ a much lower amount of radiation than scans of the kidney designed todetect cancer. More radiation is required for detection of cancer in order to distinguishbetween objects with intrinsically low differences in attenuation. Ideally, the scan protocol
should be specified, including data for different sequences if more than one is used, start and82

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end positions, tube potential, whether fixed mAs or tube current modulation is used,collimation, rotation time and pitch.

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(209)
The type of data collected will require both anatomical groupings and protocol
types. The standard anatomical groupings are separate examinations of the head, abdomen,
and chest, and combined examination of the abdomen and pelvis or chest, abdomen and pelvis.
Protocols include a variety of imaging tasks (e.g. angiography, perfusion, renal stone
identification).

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(210)
For each patient, the CTDIvol and DLP values displayed by the CT scannershould be recorded, but it is important to check the calibration. If CTDIvol is not displayed,then it will have to be calculated from the CTDIw and pitch. The DLP for the complete
examination is obtained by adding together the contributions from the individual scansequences.

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(211)
If data collection is via paper forms, the number of patients will be limited, butshould be at least 30. With restricted numbers, information on patient sizes should berecorded, if possible, or at least the range of sizes restricted with very large and very small
patients being excluded. DRL values are designed to help determine whether the amount ofionising radiation applied for a medical imaging procedure in a representative sample ofstandard-sized patients, for a defined clinical task, is too high or too low. For CT, as forradiography and fluoroscopy, it is well understood that the optimal radiation dose varies withpatient size (Samei and Christianson, 2014). It is therefore necessary to ensure that the survey
data reflect values for standard-sized patients.

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5.3.3. Cone-beam CT(212)
CBCT typically includes dental and maxillofacial CBCT systems, CBCT
utilised as an imaging modality on fluoroscopes, and radiotherapy verification systems.
Dental and maxillofacial procedures are intended to display high contrast objects (bone andair) with low radiation exposure as compared to conventional CT, whereas fluoroscopy andradiotherapy applications require visualisation of soft tissue structures and substantiallyhigher exposures, comparable to conventional CT.

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(213)
CBCT is the subject of a recent Commission’s report (ICRP, 2015). The
Commission recommends the use of PKA, Ka,r, CTDIvol and DLP as DRL quantities,
depending on availability (Table 2.3). PKA and Ka,r are more likely to be available and usefulfor fluoroscopes and dental CBCT systems (HPA, 2010), while CTDIvol and DLP are used forradiotherapy imaging systems and some dental CBCT systems.

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(214)
As of 2015, little progress has been made toward setting DRLs for CBCT.
Based on a preliminary audit of PKA values on 41 dental and maxillofacial CBCT units, HPA(2010) proposed a tentative DRL (though termed an ‘achievable dose’) of 250 mGy cm2,
normalised to an area corresponding to 4 x 4 cm at the isocentre, for placement of an upper
first molar implant in a standard adult patient. This value was adopted by the SEDENTEXCTConsortium (EC, 2012), with the remark that "further work involving large scale audits is83

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needed to establish robust DRLs" for various dental and maxillofacial CBCT applications.
This remark is also relevant for other CBCT applications. Dental and maxillofacial CBCT
procedures should not exceed the dose of comparable CT procedures for high contrast objects(typical CTDIvol <10 mGy).

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(215)
CBCT is also becoming increasingly important during interventional
fluoroscopy procedures (Wallace et al., 2008; Lightfoot et al., 2013; Corredoira et al., 2015).
It can provide information and guidance that is not otherwise available during the procedure,
and can increase the safety of the procedure (Lee et al., 2014). The portion of the administeredradiation from the procedure that is due to CBCT can be substantial. Corredoira et al. (2015)
analysed the total PKA measured in paediatric IC procedures and observed that CBCT
contributed 33% of the administered radiation in therapeutic procedures and 16% of theadministered radiation in diagnostic procedures.

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5.4. DRLs in planar and SPECT nuclear medicine imaging(216)
For the purpose of this report, planar nuclear medicine imaging refers to twodimensional (2D) imaging, utilising digital imaging detector systems, of patients who have
had radiopharmaceuticals administered. The digital detector systems normally are scintillation
gamma cameras equipped with various types of collimators. For all types of diagnostic
nuclear medicine procedures, radiopharmaceutical administration is either by injection, by
mouth or through inhalation.

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(217)
SPECT is a nuclear medicine tomographic functional imaging technique thatuses γ rays produced from administered radiopharmaceuticals. It is similar to conventional
nuclear medicine planar imaging, but uses one or more rotating gamma cameras and is able toprovide three-dimensional (3D) information. This information is typically presented as crosssectional images of the patient. These images can be freely reformatted and presented. SPECT
is mainly carried out using conventional scintillation gamma cameras, which rotate around thepatient. Recently, gamma cameras based on solid-state detectors [e.g. cadmium-zinc-telluride(CZT)] have been developed and are now commercially available.

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(218)
The administered activity of a radiopharmaceutical determines the patient dose
for a patient of standard size and standard biokinetics. Dose calculations for a number ofradiopharmaceuticals are presented in the Commission’s publications on radiation dose topatients from radiopharmaceuticals (ICRP, 1987, 1998, 2008). The Commission recently
published a compendium summarising all current information related to frequently used
substances (ICRP, 2015).

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(219)
For planar nuclear medicine imaging, DRLs are surveyed and have been set
either by administered activity (MBq) (EC, 1999) or, preferably, by administered activity perunit of body weight (MBq/kg). The latter approach is practical and simple to adopt (Roch andAubert, 2013). The Commission recommends the establishment of weight-based administeredactivities (MBq/kg) for all types of nuclear medicine investigations except for those where theradiopharmaceutical is concentrated predominantly in a single organ (e.g. thyroid, sentinelnode imaging, pulmonary ventilation and perfusion studies). Setting of a fixed maximum
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activity for very obese patients may also be considered. Appropriate administered activities
for children are discussed in Chapter 6.

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(220)
For SPECT imaging procedures, DRL values should be set in the same way as
for planar nuclear medicine procedures. The Commission recommends the establishment ofweight-based administered activities (MBq/kg). Very limited data on DRL values for SPECT
exist as of 2015 (Avramova-Cholakova et al., 2015). In some countries (e.g. the U.K.), DRL
values for SPECT studies are slightly higher than for the same radiopharmaceuticals used forplanar imaging.

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(221)
Guidance documents produced by various countries have recommended
maximum administered activities for established diagnostic procedures using specificradiopharmaceuticals (CRCPD, 2006; ARSAC, 2006; NCRP, 2012). The
recommended administered activity provided by an authority or a national association of
nuclear medicine (SNMMI, 2015; EANM, 2015) for an average adult patient may not be
entirely representative of the real situation. However, in a U.K. survey (HPA, 2008), mostnuclear medicine centres used administered activities that were very close to thoserecommended. Since the majority of hospitals and clinics use recommended administeredactivity levels or lower levels, there is less inter-departmental variation in patient dose than indiagnostic radiology. If this method is followed, individual practitioners are encouraged to use
lower administered activities if their equipment or software permits and the resultant image
quality is adequate for diagnosis.

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(222)
The administered activity for individual patients may be adjusted upwards
where there are sound clinical reasons, e.g. to allow an examination to be performed in ashorter time for a patient who is in extreme pain and cannot endure the normal investigation
time or for a patient who is obese. If the DRL will routinely be adjusted [e.g. for myocardial
perfusion imaging (Notghi et al., 2003)], a written protocol should be followed and any
potential change in the relative radiation risk (i.e. the relative increase in the administeredactivity) to a patient should always be weighed against the corresponding change in benefit(e.g. patient discomfort, accuracy of the investigation, etc.).

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(223)
In nuclear medicine, increasing the administered activity not only improves
imaging quality but also reduces acquisition time. Reducing administered activity while
maintaining image quality can be achieved by increasing acquisition time. However,prolonged acquisition times are not practical because patients cannot remain still and motion
artefacts result in blurred images. Some institutions where a large volume of nuclear medicine
procedures is performed administer more activity to patients in order to achieve higher patient
throughput. From a radiological protection point of view, this is not desirable.

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5.5. Considerations for DRL surveys for nuclear medicine(224)
DRL values for nuclear medicine imaging should be set taking into account the
principles outlined in this report, and surveys should be performed in accordance with theguidelines given in Chapter 2. It can be expected that DRL values will decrease with advances

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in technology, such as iterative reconstruction and CZT solid-state detectors (Piccinelli and
Garcia, 2015; Gunalp, 2015).

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(225)
There are specific issues that must be decided prior to setting DRLs for nuclear
medicine imaging. For most planar nuclear medicine procedures, there are only minor
variations in the activity needed. However, for some diagnostic nuclear medicine
investigations, administered activities are highly dependent on the intended procedures. An
example is for cardiac studies, where there are one-day and two-day protocols for stress andrest imaging and also variation between these procedures. It is difficult to compare
administered activities without knowing the precise protocol used. National DRL values are
based in some countries on the whole protocol with two injections, and in other countries
DRL values are provided separately for stress and rest imaging.

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(226)
Patient selection is an important aspect of setting DRL values. In nuclear
medicine, as in other imaging techniques, patient size plays an important role in thedetermination of required activity to achieve adequate image quality for a given procedure.
Generally, surveys set a patient weight range. DRL values in adult nuclear medicine arenormally based on the administered activities used for average-sized patients (i.e. 70 ± 10 kg),and then a DRL value for administered activity per unit body weight (MBq/kg) is calculated.
DRL values for paediatric nuclear medicine are discussed in Chapter 6.

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5.6. Hybrid imaging (PET/CT, SPECT/CT and PET/MRI)(227)
PET and SPECT have been combined with CT (PET/CT and SPECT/CT), andPET has been combined with MRI, because these combinations increase diagnostic accuracy
by providing both functional and anatomical images of the body.

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(228)
The acquisition of accurately co-registered anatomical and functional images isa major strength of combined modality (hybrid imaging) devices. A further important
advantage in use of the CT images is the capability for attenuation correction of the PET and
SPECT emission data. PET/CT has become one of the most rapidly growing medical imaging
modalities.

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(229)
For the purpose of this report, the terms PET/CT and SPECT/CT apply to a
hybrid imaging procedure where an imaging device that combines a nuclear medicine camera
with a CT scanner permits acquisition of a PET or a SPECT image with a CT image. Both CT
and nuclear medicine images are obtained during the same session. The patient dose from a
PET/CT or SPECT/CT examination is the combination of the radiation exposures caused by
the radiopharmaceutical and by the CT study. The MRI component of PET/MRI does notincrease patient dose, so from a radiological protection point of view, PET/MRI can beconsidered a PET scan.

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(230)
Since DRLs for nuclear medicine procedures and CT procedures apply toradiation from very different modalities, and use different DRL quantities, it is appropriate to
set and present DRL values for each modality independently. It is important that the detector
type and configuration in both PET/CT and SPECT/CT are recorded as part of the survey data

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when developing DRLs, so that differences between detector types are correctly identified.
Considerations for PET, SPECT and CT in hybrid imaging are considered below.

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5.6.1. PET(231)
PET is a nuclear medicine tomographic functional imaging technique that uses
a positron-emitting administered radiopharmaceutical that produces, as a result of positronemission decay, pairs of 511 keV γ photons at almost 180 degrees to each other. These pairsof annihilation photons are detected in a stationary detector ring around the patient. 3D
images of the activity concentration within the body are then constructed.

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(232)
Different radiopharmaceuticals may be used for PET imaging, depending on
the purpose of the study. 18F Fludeoxyglucose (18FDG) is used for diagnosing anddetermining the extent of cancer, inflammation, viable myocardium, and brain diseases by
revealing relative glucose metabolic activity in tissues and organs. 13N-ammonia or 82Rb areused to assess myocardial perfusion. 68Ga-DOTA-TATE and DOTA-TOC reflect the status ofsomatostatin receptors in various neuroendocrine tumours. Since the physical half-lives ofradionuclides and biological half-times of radiopharmaceuticals are different, DRL values
have to be set for each radiopharmaceutical. Since more than 90% of current PET
examinations use 18FDG, this section discusses only 18FDG PET and PET/CT.

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(233)
While some institutions still use fixed administered activity for adults, theCommission recommends adjusting the administered activity for patient weight. Less activity
is sufficient to generate good image quality for thin people, since attenuation and scatter
effects of γ photons in these individuals are less than those in obese individuals. U.S.
guidelines only recommend a range of 370-740 MBq for adult patients (ACR-SPR, 2014).
European guidelines provide a calculation system according to body weight, image
acquisition method (2D or 3D), scan speed (min/table position) and table overlap duringconsecutive PET acquisitions (≤30% or >30%) (Boellaard et al., 2015).

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(234)
Since increasing the administered activity will not only improve imaging
quality but also reduce acquisition time, it might seem appropriate to employ a higher-thanrecommended administered activity in order to reduce the duration of the scan, especially forobese patients. For obese subjects (>90 kg), increasing scanning time (time per table position),rather than increasing administered activity, is recommended to improve image quality.
Administered activity for 18FDG should be kept to less than 530 MBq (Boellaard, et al., 2015)
for PET-systems equipped with LYSO scintillation detectors so as not to affect the image
quality.

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(235)
Hydration and voiding are also important for patient preparation prior to a
PET/CT procedure. The patient should be encouraged to drink water and then void prior toscanning, in order to limit the radiation dose to bladder.

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(236)
Acquisition sensitivities vary, depending on the individual PET system. Older
PET systems had a 2D acquisition mode that used axial collimators. As computation powerand electronics improved, a 3D acquisition mode was developed. All collimator septa were87

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removed, resulting in a 4-8 times higher sensitivity. In 3D acquisition mode, the administeredactivity can be reduced without affecting image quality. The European Association of Nuclear
Medicine (EANM) recommends using administered activities of 380 MBq for 2D and 190
MBq for 3D for a ‘standard’ adult patient (75 ± 5 kg) (Boellaard et al., 2015).

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(237)
Newer PET/CT scanners offer time-of-flight (TOF) technology, which canhelp overcome poor signal from large patients. TOF accurately measure the actual timedifference between the detection of the two annihilation photons. This permits improved
image contrast and higher sensitivity. Use of TOF technology permits a decrease in the
average administered activity of ~20% (from 4.3 MBq/kg to 3.5 MBq/kg) without loss ofimage quality (Etard et al., 2012).

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(238)
A national survey of patients undergoing whole-body PET/CT examinations
was conducted in all French nuclear medicine departments in 2011 (Etard et al., 2012). The
average injected 18FDG activity was 4.3 MBq/kg, in agreement with contemporary European
recommendations (Boellaard et al., 2015).

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5.6.2. CT in PET/CT and SPECT/CT(239)
For CT imaging in PET/CT and SPECT/CT, patient dose depends on the
purpose of the CT examination. In the framework of a PET/CT or SPECT/CT examination,
the CT portion of the examination comprises a topogram and the helical CT scan. If the CT isused for a full diagnostic CT examination, DRL values as described in Section 5.3 areappropriate, but a lower patient dose (and thus a lower DRL value) is appropriate when CT is
performed only for attenuation correction and anatomical localisation. If a CT is solely
performed for attenuation correction and co-localisation, the acquisition parameters (tubecurrent, voltage, slice thickness, rotation time, and pitch) should be selected in order tominimise the patient’s radiation exposure.

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(240)
For a diagnostic contrast-enhanced CT, standard protocols should be used. It ispreferable to perform a diagnostic CT only for limited portions of the body. For the rest of thebody, a low-dose CT is sufficient for attenuation correction and anatomic localisation. Current
DRL values for diagnostic CT of the trunk are too high for the CT component of PET/CT if
the CT is performed only for attenuation correction and localisation. Despite wide variations
between PET/CT systems (4-fold variations in CTDIvol), CT DRL values of 8 mGy (CTDIvol)
and 750 mGy⋅cm (DLP) have been proposed for whole-body PET/CT (Etard et al., 2012).

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5.7. References

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AAPM, 2011. Size-specific dose estimates (SSDE) in Paediatric and adult body CT
examinations. Report of AAPM Task Group 204. American Association of Physicists in
Medicine. College Park, MD, AAPM.

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ACR-SPR, 2014. ACR–SPR practice parameter for performing FDG-PET/CT in oncology.
Reston,VA:
AmericanCollegeofRadiology.
Availableat:
http://www.acr.org/~/media/ACR/Documents/PGTS/guidelines/FDG_PET_CT.pdf

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3

ARSAC (Administration of Radioactive Substances Advisory Committee), 2006. Notes for
Guidance on the Clinical Administration of Radiopharmaceuticals and Use of Sealed
Radioactive Sources. Chilton: Health Protection Agency.

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Asada, Y., Suzuki, S., Minami, K., Shirakawa, S., 2014. Results of a 2011 nationalquestionnaire for investigation of mean glandular dose from mammography in Japan. J.
Radiol. Prot. 34, 125–132.
Avramova-Cholakova, S., Dimcheva, M., Petrova, E., Garcheva, M., Dimitrova, M., Palashev,
Y., Vassileva, J., 2015. Patient doses from hybrid SPECT-CT procedures. Radiat. Prot.
Dosim. 165, 424–429.
Boellaard, R., Delgado-Bolton, R., Oyen, W.J.G., Giammarile, F., Tatsch, K., Eschner, W.,
Verzijlbergen, F.J., Barrington, S.F., Pike, L.C., Weber, W.A., Stroobants, S., Delbeke,
D., Donohoe, K.J., Holbrook, S., Graham, M.M., Testanera, G., Hoekstra, O.S., Zijlstra,J., Visser, E., Hoekstra, C.J., Pruim, J., Willemsen, A., Arends, B., Kotzerke, J., Bockisch,A., Beyer, T., Chiti, A., Krause, B.J., 2015. FDG PET/CT: EANM procedure guidelines
for tumour imaging: version 2.0. Eur. J. Nucl. Med. Mol. Imaging 42, 328–354.
Corredoira, E., Vañó, E., Ubeda, C., Gutiérrez-Larraya, F., 2015. Patient doses in paediatricinterventional cardiology: impact of 3D rotational angiography. J. Radiol. Prot. 35, 179–
195.
CRCPD, 2003. Use of radionuclides in the healing arts. In: Suggested State Regulations forControl of Radiation, Volume I, (Ionising Radiation) Part G, CRCPD dynamic document.
Conferenceof
Radiation
Control
ProgramDirectors.
Availableat:
http://www.crcpd.org/SSRCRs/gpart.pdf.
EANM, 2015. Guidelines. European Association of Nuclear Medicine. Vienna.
http://www.eanm.org/publications/guidelines/index.php?navId=37&PHPSESSID=okn9u
umdi20mmfjuop6edr7j87
EC, 1999. Radiation Protection No. 109. Guidance on diagnostic reference levels (DRLs) for
medical exposures. Luxembourg: European Commission.
EC, 2012. Radiation Protection No. 172. Cone beam CT for dental and maxillofacial
radiology - evidence based guidelines. Luxembourg: European Commission. Available
at: http://www.sedentexct.eu/content/guidelines-cbct-dental-and-maxillofacial-radiology
Etard, C., Celier, D., Roch, P., Aubert, B., 2012. National survey of patient doses from wholebody FDG PET-CT examinations in France in 2011. Radiat. Prot. Dosim. 152, 334–338.
EU, 2006. European guidelines for quality assurance in breast cancer screening and diagnosis[4th Edition], Luxembourg: Office for Official Publications of the European Communities.
Available at http://www.euref.org/downloads?download=24:european-guidelines-forquality-assurance-in-breast-cancer-screening-and-diagnosis-pdf
Foley, S.J., McEntee, M.F., Rainford, L.A., 2012. Establishment of CT diagnostic reference
levels in Ireland. Br. J. Radiol. 85, 1390–1397.
Gunalp, B., 2015. Role of cardiac ultrafast cameras with CZT solid-state detectors andsoftware developments on radiation absorbed dose reduction to the patients. Radiat. Prot.
Dosim. 165, 461–463.
HPA, 2008. Frequency and Collective Dose for Medical and Dental X-Ray Examinations in
the UK. Report HPA-CRCE-012.Chilton: Health Protection Agency (UK).

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HPA, 2010. Recommendations for the design of x-ray facilities and the quality assurance ofdental cone beam CT (computed tomography) systems. Report HPA-RPD-065. Chilton:
Health Protection Agency (UK).
ICRP, 1987. Radiation dose to patients from radiopharmaceuticals. ICRP Publication 53. Ann.
ICRP 18(1–4).
ICRP, 1998. Radiation dose to patients from radiopharmaceuticals. Addendum 2 to ICRP
Publication 53. ICRP Publication 80. Ann. ICRP 28(3).
ICRP, 2004. Managing Patient Dose in Digital Radiology. ICRP Publication 93. Ann. ICRP
34(1).
ICRP, 2007. Managing Patient Dose in Multi-Detector Computed Tomography, ICRP
Publication 102. Ann. ICRP 37(1).
ICRP, 2008. Radiation dose to patients from radiopharmaceuticals. Addendum 3 to ICRP
Publication 53. ICRP Publication 106. Ann. ICRP 38(1/2).
ICRP, 2015. Radiation dose to patients from radiopharmaceuticals. A compendium of current
information related to frequently used substances. ICRP Publication 128. Ann. ICRP
44(2S)IPEM, 2004. Report 88, Guidance on the establishment and use of Diagnostic Reference
Levels for Medical X-Ray Examinations.
Lee, S.M., Park, C.M., Lee, K.H., Bahn, Y.E., Kim, J.I., Goo, J.M., 2014. C-arm cone-beamCT-guided percutaneous transthoracic needle biopsy of lung nodules: clinical experiencein 1108 patients. Radiology 271, 291–300.
Lightfoot, C.B., Ju, Y., Dubois, J., Abdolell, M., Giroux, M.F., Gilbert, P., Therasse, E., Oliva,
V., Soulez, G., 2013. Cone-beam CT: an additional imaging tool in the interventional
treatment and management of low-flow vascular malformations. J. Vasc. Interv. Radiol.
24, 981–988. e2.
Morin, R.L., Coombs, L.P., Chatfield, M.B., 2011. ACR Dose Index Registry. J. Am. Coll.
Radiol. 8, 288–291.
NCRP, 2009. Ionizing radiation exposure of the population of the United States. NCRP
Report 160. National Council on Radiation Protection and Measurements. Bethesda, MD.
NCRP, 2012. Reference Levels and Achievable Doses in medical and dental imaging:recommendations for the United States. NCRP Report 172. National Council on
Radiation Protection and Measurements. Bethesda, MD.
Notghi, A., Williams, N., Smith, N., Goyle, S., Harding, L.K., 2003. Relationship between
myocardial counts and patient weight: adjusting the injected activity in myocardial
perfusion scans. Nucl. Med. Commun. 24, 55–59.
Piccinelli, M., Garcia, E.V., 2015. Advances in software for faster procedure and lower
radiotracer dose myocardial perfusion imaging. Prog. Cardiovasc. Dis. 57, 579–587.
Roch, P., Aubert, B., 2013. French diagnostic reference levels in diagnostic radiology,
computed tomography and nuclear medicine: 2004–2008 Review. Radiat. Prot. Dosim.
154, 52–75.
Samei, E., Christianson, O., 2014. Dose index analytics: more than a low number. J. Am. Coll.
Radiol. 11, 832–834.

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Shrimpton, P.C., Hillier, M.C., Meeson, S., Golding, S.J., 2014. Doses from computed
tomography (CT) examinations in the UK – 2011 review. (Public Health England:
Chilton) PHE-CRCE-013.
SNMMI, 2015. Procedure Standards. Society of Nuclear Medicine and Molecular Imaging.
Reston, VA. https://www.snmmi.org/ClinicalPractice/content.aspx?ItemNumber=6414
Wallace, M.J., Kuo, M.D., Glaiberman, C., Binkert, C.A., Orth, R.C., Soulez, G., 2008.
Three-dimensional C-arm cone-beam CT: applications in the interventional suite. J. Vasc.
Interv. Radiol. 19, 799–813.
Williams, M.B., Krupinski, E.A., Strauss, K.J., Breeden, W.K., Rzeszotarski, M.S., Applegate,
K., Wyatt, M., Bjork, S., Siebert, J.A., 2007. Digital radiography image quality: image
acquisition. J. Am. Coll. Radiol. 4, 371–388.

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6.

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PAEDIATRICS

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Establishing DRLs for children is more challenging than for adults, due to thebroad range of sizes and ages of paediatric patients. Weight in children can varyby a factor of more than 100 from a premature infant to an obese adolescent. A
single ‘standard patient’ should not be used to define DRLs for paediatricimaging.
The amounts of administered radiation for examinations of children can varytremendously due to the great variation in children’s size and weight. Variationin patient dose due to patient weight is appropriate, but variation in patient dose
due to inappropriate technique or failure to adapt the imaging protocol to patient
size and the clinical task is not.
The smaller body size of most children, as compared to adults, means that inchildren more organs are likely to be within or near the primary beam, so thatprecise collimation is both more important and more difficult. For projection
radiography, the relevance of appropriate collimation is higher in paediatrics.
Patient age categories have been used in the past to define groups of children forthe purpose of establishing paediatric DRLs. It has become apparent that age
alone is not a good indicator. Weight categories are preferred, and should be
used whenever possible.
Weight bands (with 10 kg intervals) are recommended for establishing paediatric
DRLs. Weight bands should be promoted for paediatrics. Age bands (<1 y; 1-<5y; 5-<10 y and 10-<16 y) can be used if age is the only available measure.
To overcome the problem of collecting sufficient data, caused by the need forweight bands and the general paucity of dosimetric data for patients in paediatricimaging, it has been suggested that the DRL quantity can be presented as afunction of patient weight instead of presentation in weight bands. This option
should be explored further.
For CT, the DRL quantities are CTDIvol and DLP, based on calibration with a 32
cm phantom for body examinations and a 16 cm phantom for head examinations.
Values for these quantities should be obtained from patient examinations.
Modern CT scanners permit determination of effective diameter or patient
equivalent thickness. This should be considered as an additional refinement for
setting paediatric DRL values. Size-specific dose estimates (SSDE) may be used inaddition to the recommended DRL quantities as an additional source of
information for optimisation.
For nuclear medicine imaging, DRLs are surveyed and DRL values are set byadministered activity (MBq) or administered activity per unit of body weight(MBq/kg), since this approach is both practical and simple. Activities foradministration should be adjusted based on agreed factors linked to size or
weight.

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When regional or national DRL values are not available, local practice may becompared to appropriate available published data. This is especially relevant for
paediatrics due to the scarcity of national or regional DRLs.

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6.1. Considerations relevant to paediatric DRLs
(241)
Optimisation of paediatric imaging is of particular importance, because the riskof many harmful radiation effects is greater in children than in adults and they have a longer
life expectancy during which these effects may manifest. Moreover, the smaller body size ofmost children as compared to adults means that in children more organs are likely to be withinor near the primary beam, so that precise collimation is both more important and moredifficult (ICRP, 2013). The short exposure times required for paediatric examinations meanthat manual exposures are often used instead of AEC systems.

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(242)
The amount of administered radiation for examinations of children can varytremendously due to the great variation in patient size and weight, from neonates to adultsized adolescents. This variation in patient radiation dose is appropriate. However, additionalvariation in patient radiation dose may occur, due to inappropriate technique or to failure toadapt imaging protocols to account for both paediatric diseases and paediatric patient sizes.
This variation in patient radiation dose is not appropriate. Weight or size-adjusted paediatric
DRLs are therefore particularly important as an aid in optimisation. Simple adaptation of
adult imaging protocols to account for paediatric diseases and patient sizes is not acceptable.

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(243)
A number of factors need to be considered when discussing developing DRLs
for children. Some factors are the same for adults and children. These include the choice of
DRL quantities, the percentile of the distribution of the DRL quantity, and whether to use
surveys of patients or measurements with phantoms. For other factors, particularly patient
weight and size, specific considerations apply for children.

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(244)
DRLs for adults are defined for a ‘standard patient’. For children, there cannot
be a single standard patient, due to the large size range of paediatric patients. Adults vary inbody weight by approximately a factor of 4 (40–160 kg), while weight in children can vary bya factor of more than 100, from that of a premature infant (300-400 g) to that of an obese
adolescent (>100 kg). Within the first six months of life, a typical baby’s body weight doubles,and during the first year, it increases threefold. The AAPM uses several different standard
paediatric phantoms to help in optimisation for paediatric imaging (AAPM, 2011).

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(245)
The Commission has not previously provided guidance on representative childsizes for defining paediatric DRLs. In the past, patient age has been used to define groups ofchildren for the purpose of establishing paediatric DRLs. Typically ages of 0 (neonate), 1, 5,
10 and 15 years have been used (ICRP, 2007, 2013), mirroring available standard phantoms.
To ensure reasonably accurate results, data for at least 30 patients in a particular age groupshould be collected if patient weight is not known (Section 2.3.3). A recent paper suggests a
pragmatic approach of using four age groups, <1 y, >1-5 y, >5-10 y, >10-15 y (Vassileva andRehani, 2015). However, there are large variations, even within these groups, and Kleinman
et al. (2010) have demonstrated that individual patient size does not correlate well with patient

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age, even though fitted average patient sizes are age-dependent. This study suggested that it ispreferable to use groupings based on paediatric patient body size, and that body size should bedetermined for individual patients before performing diagnostic imaging procedures thatentail radiation risk.

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(246)
Weight is a more reliable factor to link with the DRL quantity than age(Järvinen et al., 2012). Use of weight bands should be promoted. A number of different
grouping schemes for patient size and for patient weight have been described in the literature.
The Commission recommends the use of weight bands, generally with 10 kg intervals with
about seven groupings. Age bands (<1 y; 1-<5 y; 5-<10 y and 10-<16 y) can be used if age isthe only available measure. If weight is available, this parameter should be collected topresent DRLs in the form of weight bands. In the future, DRLs based on patient dimensions
could also be used.

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(247)
For future DRL surveys, DRL values based on patient age will be of value
primarily to facilitate comparison with older data. Note, however, that empirical equivalencies
have been studied to convert existing age-based data into corresponding patient sizes forcomparison of weight-based data with older data (AAPM, 2011; Seidenbusch and Schneider2014).

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(248)
For local DRLs, and for comparison with national or regional DRLs, the mean
weight in the facility’s data should be within 5-10% of the mean weight of the sample onwhich the DRLs were based. Comparison of results from different surveys should always be
performed with caution, taking into consideration the method of grouping paediatric patients.

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(249)
Recent research has led to efforts to develop indices that more closely correlatewith radiation attenuation in paediatric patients. Most modern radiography, fluoroscopy andCT systems have some form of automatic exposure control or tube current modulation. The
exposure is determined by effective attenuation in the path of the x-ray beam. For CT
scanners, attenuation and tube current can vary throughout each scan rotation. In order todevelop useful values for paediatric DRLs, consideration should be given in the future togrouping survey data into attenuation-based bands.

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(250)
For radiography, fluoroscopy, and nuclear medicine examinations, weightshould be used as the parameter for grouping paediatric patients into categories for the
purpose of determining DRL values and evaluating local practice.

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(251)
Updating of existing paediatric DRLs has been very slow in comparison withthe rapid development of imaging technology. In most countries, current paediatric DRLs are
the first ones ever implemented, and were established many years ago. Only a few countries
have trend data for paediatric procedures based on successive surveys of DRL quantities.

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(252)
Since paediatric imaging is performed only occasionally in most hospitals, datacollection for these examinations is a particular problem. There are likely to be only a few
examinations in any age, weight or size group in a typical hospital. In view of these limited
numbers, surveys to establish DRL values may need to focus primarily on the main hospital(s)94DRAFT REPORT FOR CONSULTATION: DO NOT REFERENCE

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in the region that provide paediatric imaging. An alternative to surveys is the establishment ofa registry to which healthcare facilities submit dose data.

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(253)
To overcome the problem of insufficient data caused by the need for several
patient groups, and the general paucity of data for DRL quantities in paediatric imaging, it has
been suggested that the DRL quantity could be presented as a function of patient weight
instead of by presentation in weight bands. Patient equivalent thickness could also be used for
CT. An example of the data used to define a DRL quantity-weight curve is shown in Fig. 6.1(Kiljunen et al., 2007; Järvinen et al., 2015). To compare local patient data with this curve, theuser obtains data for a limited number of patients (e.g. ten consecutive patients) regardless of
their age, size or weight, and overlies these data points on the DRL quantity-weight curve.
This alternative has been used with some success in Scandinavia, but as of 2015 experience islimited.

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Fig. 6.1. An example of DRL quantity-weight curves for CT of the chest, with DLP as the
DRL quantity. “Eksp” means exponential fitting. The DLP values relate to the 32 cm diameter95

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CT dosimetry phantom. The lowest curve shows an example of using this methodology toprovide comparison for a limited data set from an individual hospital (Järvinen et al., 2015).

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6.2. Paediatric DRLs for CT(254)
CTDIvol and DLP for patient examinations are determined by reference to a
specific standard reference phantom, either 16 cm (head) or 32 cm (body) in diameter. For agiven patient's CT scan, CTDIvol and DLP are displayed on the CT console for the reference
phantom selected by the scanner. In general, for examinations using a head bow-tie filter orhead scan protocol, the 16 cm diameter phantom is used. For examinations of the chest, whena body bow-tie filter or body scan protocol is used, the 32 cm diameter phantom is used. Until
recently, some manufacturers used the 16 cm diameter phantom and others used the 32 cm
diameter phantom as the reference for calculating CTDIvol and DLP for paediatric body CT
protocols. In 2012, the IEC amended the CT standard to specify that a 32 cm phantom should
be used for all body examinations, both paediatric and adult (IEC, 2012).

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(255)
To compare CTDIvol or DLP values for patient examinations on a specific CT
scanner to other reported values, the phantom diameter used for the specific scanner modeland software version must be known. In most cases, the phantom diameter used is now
displayed on the user console along with CTDlvol and DLP, or is present in the DICOM report.
Older scanner models and software versions, however, may not provide this information in areadily accessible location. The scanner manufacturer should be consulted in such case.

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(256)
Phantom size does not address issues of patient size, and patient size has alarge effect on the amount of radiation applied for a procedure. AAPM Report 204 introduced
a parameter known as the Size-Specific Dose Estimate (SSDE) to allow estimation of patient
dose based on CTDIvol and patient size (AAPM, 2011). The SSDE is the CTDIvol adjusted forpatient equivalent thickness based on a set of standard coefficients.

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(257)
Some caution is required in interpreting CTDIvol and DLP data for smaller
paediatric patients. If a 32 cm phantom is used to determine the reference CTDIvol, rather thana 16 cm phantom, patient dose could be underestimated by a factor of 2-3. SSDE calculations
take into account the effect of different phantom diameters, so if the phantom diameter isknown (as it should be), its effect on patient dose will be accounted for.

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(258)
DRLs for paediatric CT are available for very limited types of examinations
and were included in earlier ICRP publications (ICRP, 2007, 2013; Vassileva and Rehani,
2015; Vassileva et al., 2015). In some cases, it is not clear whether the CTDIvol values werebased on 16 or 32 cm phantoms. Also, automatic tube current modulation may not have beenused when the earlier DRL values were determined. When it can be employed, the use of tube
current modulation for CT scan protocols may reduce patient doses.

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(259)
For CT, many current scanners permit determination of an effective diameteror patient equivalent thickness. The patient equivalent thickness is derived from the patient’s
anteroposterior (AP) and lateral dimensions (effective diameter = √[AP×LAT]). When both39

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the AP and lateral dimensions of the patient are known, the product of these two dimensions
can be used to estimate effective diameter.

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(260)
Use of patient equivalent thickness for grouping patients for the purpose ofdetermining DRLs may be considered as an alternative or additional refinement.
Manufacturers are encouraged to provide the capability to determine and record theseparameters so that they are included in patient image files, along with values of the DRL
quantities, in order to make them readily available for refining the determination of DRL
values.

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(261)
ICRU Report 74 provides data on the relationship of patient effective diameterto age (ICRU, 2005). These data can be used to correlate age and effective diameter, but age
should only be used to facilitate comparisons with older data. Dose estimates based on patient
size are considered more accurate and should be used when size information is available(AAPM, 2011).

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6.3. Paediatric DRLs for radiography, nuclear medicine and interventional procedures(262)
There is a need to establish DRLs for radiography, nuclear medicine andinterventional procedures. The DRL quantities recommended for adults apply equally topaediatric DRLs. Other considerations relevant to adult DRLs also apply to paediatric DRLs
except that, as discussed in Section 6.1, patient size and weight are of critical importance for
paediatric DRLs.

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(263)
During the last three decades, the U.K. has demonstrated the widest experiencein periodically reviewing and revising DRLs for paediatric imaging. Even in the U.K.,
paediatric DRL values have been established only for very limited types of examinations (e.g.
for radiography, only for examinations of the skull, chest, abdomen, and pelvis). Whenapplicable regional or national DRL values are not available, local practice may be compared
to any available published data.

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(264)
For diagnostic fluoroscopy, current national DRL values in European countries
are given only for micturating cystourography (MCU) except in the U.K., where DRL values
have also been set for barium meal and barium swallow examinations. All the DRL values forfluoroscopy use PKA as the DRL quantity. There are no current national DRLs for paediatric
IR or IC. Attempts at establishing local paediatric DRLs for interventional procedures havebeen made in a number of countries, mainly in Europe but also in Asia (IAEA, 2009;
Kloeckner et al., 2012; Tsapaki et al., 2008; Vitta et al., 2009).

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(265)
For nuclear medicine imaging, DRLs are surveyed and DRL values are set
using administered activity (MBq) or administered activity per unit of body weight (MBq/kg)
as the DRL quantity, since this approach is both practical and simple. Activities foradministration to children should be adjusted based on agreed factors linked to size or weight(Lassmann et al., 2007, 2014). Standardisation of administered activities and the use ofadministered activity/weight charts are important for all paediatric nuclear medicine

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procedures, as sizable variations in administered activity have been shown to occur when they
are not used.

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(266)
Weight-based radiopharmaceutical consensus values have been developed by
EANM (www.eanm.org) and Image Gently for nuclear medicine/PET imaging(www.imagegently.org). Weight-based activities for paediatric nuclear medicine are available
in several countries. These have been tested in children's hospitals to ensure that adequate
image quality is maintained with optimised radiological protection. A compendium thatsummarises current information for frequently used substances was published in 2015 (ICRP,
2015). However, caution should be exercised to ensure that the amount of activity
administered is not so low as to give a non-diagnostic examination.

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6.4. References
AAPM. Size-Specific Dose Estimates (SSDE) in Pediatric and Adult Body CT Examinations
Report of AAPM Task Group 204, 2011.
Barnaoui, S., Rehel, J.L., Baysson, H., Boudjemline, Y., Girodon, B., Bernier, M.O., Bonnet,
D., Aubert, B., 2014. Local reference levels and organ doses from paediatric cardiac
interventional procedures. Pediatr. Cardiol. 35, 1037–1045.
Brady, Z., Ramanauskas, F., Cain, T.M., Johnston, P.N., 2012. Assessment of paediatric CT
dose indicators for the purpose of optimisation. Br. J. Radiol. 85, 1488–1498.
Dragusin, O., Gewillig, M., Desmet, W., Smans, K., Struelens, L., Bosmans, H., 2008.
Radiation dose survey in a paediatric cardiac catheterisation laboratory equipped with
flat-panel detectors. Radiat. Prot. Dosim. 129, 91–95.
Galanski, M., Nagel, H.D., Stamm, G. Paediatric CT exposure practice in the Federal
Republic of Germany: results of a nationwide survey in 2005–2006. Hannover,Germany: Medizinische Hochschule Hannover; 2007.
IAEA, 2009. Establishing guidance Levels in x ray guided Medical interventional Procedures:
A pilot study. IAEA, Vienna, Austria, STI/PUB/1346.
ICRP, 1996. Radiological protection and safety in medicine. ICRP Publication 73. Ann. ICRP
26(2).
ICRP, 2007. Managing patient dose in multi-detector computed tomography (MDCT). ICRP
Publication 102. Ann. ICRP 37(1).
ICRP, 2013. Radiological Protection in Paediatric Diagnostic and Interventional Radiology.
ICRP Publication 121. Ann. ICRP 42(2).
ICRP, 2015. Radiation dose to patients from radiopharmaceuticals. A compendium of current
information related to frequently used substances. ICRP Publication 128. Ann. ICRP
44(2S).
ICRU, 2005. Patient dosimetry for x-rays used in medical imaging. Report 74. J. ICRU 5, 1–
113.
IEC, 2012. Medical electrical equipment – Part 2-44: Particular requirements for the basic
safety and essential performance of X-ray equipment for computed tomography. IEC
60601-2-44, ed 3.1. IEC, Geneva.

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Järvinen, H., Merimaa, K., Seuri, R., Tyrväinen, E., Perhomaa, M., Savikurki-Heikkilä, P.,
Svedström, E., Ziliukas, J., Lintrop, M., 2011. Patient doses in paediatric CT: feasibilityof setting diagnostic reference levels. Radiat. Prot. Dosim. 147, 142–146.
Järvinen, H., Seuri, R., Kortesniemi, M., Lajunen, A., Hallinen, E., Savikurki-Heikkilä, P.,
Laarne, P., Perhomaa, M., Tyrväinen, E., 2015. Indication based national diagnostic
reference levels for paediatric CT: a new approach with proposed values. Radiat. Prot.
Dosim. 165, 86–90.
Kiljunen, T., Järvinen, H., Savolainen, S., 2007. Diagnostic reference levels for thorax X-ray
examinations of paediatric patients. Br. J. Radiol. 80, 452–459.
Kleinman, P.L., Strauss, K.J., Zurakowski, D., Buckley, K.S., Taylor, G.A., 2010. Patient size
measured on CT images as a function of age at a tertiary care children’s hospital. AJR
Am. J. Roentgenol. 194, 1611–1619.
Kloeckner, R., Bersch, A., dos Santos, D.P., Schneider, J., Düber, C., Pitton, M.B., 2012.
Radiation exposure in nonvascular fluoroscopy-guided interventional procedures.
Cardiovasc. Intervent. Radiol. 35, 613–620.
Lassmann, M., Biassoni, L., Monsieurs, M., Franzius, C., Jacobs, F., for the EANM
Dosimetry and Paediatrics Committees, 2007. The new EANM paediatric dosage card.
Eur. J. Nucl. Med. Mol. Imaging 34, 796–798.
Lassmann, M., Treves, S.T., for the EANM/SNMMI Paediatric Dosage Harmonization
Working Group, 2014. Paediatric radiopharmaceutical administration: harmonization of
the 2007 EANM paediatric dosage card (version 1.5.2008) and the 2010 North American
consensus guidelines. Eur. J. Nucl. Med. Mol. Imaging 41, 1036–1041.
Martinez, L.C., Vano, E., Gutierrez, F., Rodriguez, C., Gilarranz, R., Manzanas, M.J., 2007.
Patient doses from fluoroscopically guided cardiac procedures in paediatrics. Phys. Med.
Biol. 52, 4749–4759.
McCollough, C.H., Leng, S., Yu, L., Cody, D.D., Boone, J.M., McNitt-Gray, M.F., 2011. CT
Dose index and patient dose: they are not the same thing. Radiology 259, 311–316.
McFadden, S., Hughes, C., D’Helft, C.I., McGee, A., Rainford, L., Brennan, P.C., McCrumGardner E., Winder, R.J., 2013. The establishment of local diagnostic reference levels for
paediatric interventional cardiology. Radiography 19, 295–301.
Onnasch, D.G., Schröder, F.K., Fischer, G., Kramer, H.-H., 2007. Diagnostic reference levels
and effective dose in paediatric cardiac catheterization. Br. J. Radiol. 80, 177–185.
Papadopoulou, D., Yakoumakis, E., Sandilos, P., Thanopoulos, V., Makri, T., Gialousis, G.,
Houndas, D., Yakoumakis, N., Georgiou, E., 2005. Entrance radiation doses during
paediatric cardiac catheterisations performed for diagnosis or the treatment of congenital
heart disease. Radiat. Prot. Dosim. 117, 236–240.
Seidenbusch, M.C., Schneider, K., 2014. Conversion coefficients for determining organ doses
in paediatric pelvis and hip joint radiography. Pediatr. Radiol. 44, 1110–1123.
Shrimpton, P.C., Hillier, M.C., Lewis, M.A., Dunn, M., 2005. Doses from computed
tomography (CT) examinations in the UK: 2003 review. Report NRPB-W67 Chilton,
UK: National Radiological Protection Board.
Tsapaki, V., Kottou, S., Korniotis, S., Nikolaki, N., Rammos, S., Apostolopoulou, S.C., 2008.
Radiation doses in paediatric interventional cardiology procedures. Radiat. Prot. Dosim.
132, 390–394.
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Vassileva, J., Rehani, M.M., 2015. Patient grouping for dose surveys and establishment of
diagnostic reference levels in paediatric computed tomography. Radiat. Prot. Dosim. 165,
81–85.
Vassileva, J., Rehani, M., Kostova-Lefterova, D., Al-Naemi, H.M., Al Suwaidi, J.S., Arandjic,
D., Bashier, E.H., Kodlulovich Renha, S., El-Nachef, L., Aguilar, J.G., Gershan, V.,
Gershkevitsh, E., Gruppetta, E., Hustuc, A., Jauhari, A., Kharita, M.H., KhelassiToutaoui, N., Khosravi, H.R., Khoury, H., Kralik, I., Mahere, S., Mazuoliene, J., Mora,P., Muhogora, W., Muthuvelu, P., Nikodemova, D., Novak, L., Pallewatte, A., Pekarovič,
D., Shaaban, M., Shelly, E., Stepanyan, K., Thelsy, N., Visrutaratna, P., Zaman, A., 2015.
A study to establish international diagnostic reference levels for paediatric computed
tomography. Radiat. Prot. Dosim. 165, 70–80.
Verdun, F.R., Gutierrez, D., Vader, J.P., Aroua, A., Alamo-Maestre, L.T., Bochud, F.,
Gudinchet, F., 2008. CT radiation dose in children: a survey to establish age-based
diagnostic reference levels in Switzerland. Eur. Radiol. 18, 1980–1986.
Vitta, L., Raghavan, A., Morrell, R., Sprigg, A., 2009. Fluoroscopy-guided insertion ofnasojejunal tubes in children - setting local diagnostic reference levels. Pediatr. Radiol.
39, 1203–1208.
Watson, D.J., Coakley, K.S., 2010. Paediatric CT reference doses based on weight and CT
dosimetry phantom size: local experience using a 64-slice CT scanner. Pediatr. Radiol.
40, 693–703.

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7.

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APPLICATION OF DRLS IN CLINICAL PRACTICE

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Local surveys of DRL quantities should normally be carried out as part of theclinical audit for diagnostic radiography and diagnostic fluoroscopy. A
representative selection of examinations for each x-ray unit should be surveyed atintervals of about three years, and when substantial changes in technology orsoftware have been introduced.
Local surveys of DRL quantities, as part of the clinical audit, should be more
frequent (annual) for CT and interventional procedures. Annual surveys are also
appropriate as part of the clinical audit for SPECT/CT and PET/CT.
Median values of DRL quantities for diagnostic procedures for a specific x-ray
room or for a radiology department or other facility should be compared with
DRL values to identify whether the local median values are substantially higher
or lower than might be anticipated, so that the management of radiologicalprotection can be reviewed and optimised if necessary.
A DRL value is considered to be exceeded when the local median value of a DRL
quantity for a representative sample of standard-sized patients is greater thanthe DRL value.
DRLs should never be applied to individual patients, as some patients will
require higher amounts of administered radiation than others due to their size, aparticular diagnosis, or the complexity of the procedure.
If an audit reveals that a local or national DRL value is ‘consistently exceeded’(i.e. the median value in a particular facility exceeds the local or national DRL
value), an investigation should be undertaken without undue delay and an
appropriate corrective action plan should be implemented and documented.
The investigation should include review of equipment performance, the settings
used, and the examination protocols. The factors most likely to be involved aresurvey methodology, equipment performance, procedure protocol, operator skill
and, for interventional techniques, procedure complexity.
When corrective action to optimise protection is required, it is necessary to keep
in mind that DRL values are not dose limits.
In the optimisation process, account must always be taken of the image qualityand diagnostic information required for the medical imaging task. Image quality
must always be adequate to provide the information required for the clinicalpurpose of the examination.
The median (the 50th percentile) of the national or regional DRL survey
distribution represents what can be accomplished with radiological practice that
optimises dose management with respect to clinical image quality goals. These101

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median values provide additional information that can assist in optimising image
quality and patient dose.
When the median value of a DRL quantity at a facility is lower than the medianvalue of the benchmark national or regional DRL survey distribution, image
quality (or diagnostic information, when multiple images are used) should be
examined as a priority in the review.
The DRL audit process does not stop after a single assessment. Repeat surveys
are required following any optimisation, and the whole process should be
repeated after an appropriate time interval.
If continuous collection of data on DRL quantities is possible through automatedcollation of data from electronic databases, then the dose management process
may take the form of a regular review of all the data to identify any adverse
trends.

7.1. Patient audits of DRL quantities for x-ray examinations(267)
Local surveys of DRL quantities should be undertaken routinely in healthcare
facilities where imaging procedures are performed with ionising radiation. These are part ofthe clinical audit process, and are performed for guidance on performance and whether
optimisation is required. They may also contribute to the setting of national or regional DRL
values. Facility audits are normally carried out for a representative selection of examinations
for each x-ray unit. In regions with limited infrastructure for data collection, intervals of about
three years will be appropriate for many diagnostic radiography and diagnostic fluoroscopy
examinations if there are no substantial changes in equipment or software. Annual audits arerecommended for CT and interventional procedures (Fig. 7.1), because they subject patients
to higher amounts of radiation. As automated systems for patient data collection andmanagement become more widely available, the frequencies for audits of all examinations
should be reduced to annual. If continual collection of data on DRL quantities is possible
through automated collection of data from electronic databases, then the dose management
process may take the form of a regular review of all the data to identify any adverse trends at
as early a stage as possible.

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Fig. 7.1. Example of audit cycle and optimisation flow chart.

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(268)
When new imaging equipment is introduced, or changes are made to such
equipment that have the potential to affect patient dose, acceptance testing should be
performed to ensure that the equipment is functioning properly. A survey of patient doses
should then be undertaken, within the first year and once practices have become established,in order to determine whether local median values of DRL quantities have changed.

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(269)
The DRL process provides a tool through which x-ray examinations,equipment and facilities using higher radiation doses can be identified. However, this is justthe start of the dose audit process. Once equipment and procedures have been identified, staff
need to undertake corrective action in order to optimise protection. This responsibility mustbe given to appropriate staff who have the necessary expertise. The groups of staff involved
will depend on arrangements in each country or region, and may be medical physicists,
radiographers, medical physics technologists, or radiologists who may be employed by thehealthcare provider or under contract to the provider (Martin et al., 2013). Those responsible
may also in some cases be employed directly by the responsible government department.

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7.1.1. Setting up an audit programme in healthcare faciities(270)
Each facility should review carefully which examinations ought to be included
in local audits. The following criteria should be considered when identifying examinations forinclusion in the survey programme:

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a. Examinations must be performed at a reasonable frequency in the facility andshould be representative of all equipment.
b. Audits should not be limited to the radiology department or outpatient radiology
facility, but should include all areas of the facility where ionising radiation is used
for medical or dental imaging.
c. Examinations should be representative of the clinical workload of the facility.
d. Data collection must be feasible.
e. Ideally, there should be at least one examination performed on each item ofequipment that makes a significant contribution to the workload of the department.
(271)
Other aspects that should be taken into account are:

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a. Examinations should cover the work of all groups of operators who carry out x-ray
procedures in the department, i.e. radiographers (also known as radiologic
technologists), radiologists, non-radiologist clinicians (e.g. cardiologists, surgeons)and others.
b. It is helpful to include examinations for which there is a national DRL or othercomparator available, although this is not essential.
c. More examinations than necessary should not be included, as analysis can be time
consuming.
d. For fluoroscopy, most complex examinations should be suitable for thedevelopment of protocols, and many will also be well suited for setting of local
DRLs.
(272)
When the specific examinations to be included have been determined, the nextstages are to identify the rooms to be audited and the procedures carried out in those rooms,
and to decide how to obtain data on the DRL quantities. For hospitals, audits of mobile
fluoroscopy and radiography equipment should also be considered.

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(273)
As discussed in Section 2.3.3, surveys for a particular examination should
generally include at least 20 patients and preferably 30 or more for diagnostic fluoroscopy
examinations (IPSM, 1992) and 50 patients for mammography. All the selection criteria andmethods for collection discussed in Section 2.3 apply. A suitable weight selection criterion
should be chosen, with the aim of achieving the mean weight chosen for the DRL. Commonly,
the weight criterion has been 70 ± 10 kg or 70 ± 20 kg, with the goal of a mean weight of 70 ±5 kg. The weight inclusion criterion can be relaxed if data from a RIS or PACS for a large
number of examinations are analysed.

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(274)
Surveys of DRL quantities for paediatric examinations (see Chapter 6) are
more difficult to carry out because examinations of children are performed less frequently inmost hospitals, and the numbers of patients within any age/weight range are likely to be small.
Local surveys of DRL quantities in smaller hospitals may have to be based on standard factors

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used by radiology staff for children of different weights/ages. This can still be useful, as it
helps identify where the factors that would be used are inappropriate, so that operators canreview them and ensure that they are correct when examinations are required.

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(275)
Comparisons of the medians of all the DRL quantities for each examination
with the relevant DRL values are then used to identify procedures within a department for
which further optimisation is required (Fig. 8.1). Since neither the DRL value nor themeasured DRL quantity is without uncertainty, the direct comparison of the two numbers
should take the uncertainty into account when the number of patients is limited. Forinterventional procedures, comparison with the relevant DRL values should, when possible,
take into account the level of complexity of the procedures in the sample. When thisinformation is not available, median, 25th and 75th percentile values of the facility data
should be compared to the corresponding percentile values of the benchmark data. Ideally,
data shoulld be collected for all cases of the procedure at the facility.

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(276)
Where collection of data is only possible for small numbers of patients, theuncertainty in the median or mean could be large. The interquartile range serves as anindicator of dispersion of the data. While the Commission recommends use of median values
in preference to mean values, it may be helpful to consider the standard error of the mean =SD/√N, where N is the number of data points (number of examinations surveyed). The meanfor 95% of results will lie within two standard errors of the true mean. Although this is not theerror of the median, it gives an indication of the reliability of the comparison. A larger
number of examinations should be included in the survey when the range of patient sizes islarger.

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7.1.2. Audits for dental radiography(277)
The application of DRLs is important in dental radiography, because changes
in x-ray equipment exposure settings required to take advantage of the introduction of moresensitive imaging methods are not frequently made when new techniques are introduced (e.g.
use of faster E- or F-speed film instead of D-speed, or digital radiography receptors).
Establishment of national or regional DRL values for adult and child examinations is
recommended in terms of single values, but because of the substantial increase in sensitivityof digital radiography (DR) over film and CR, the introduction of separate local DRL values
for DR systems can prove useful (Martin, 2016).

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(278)
The method for managing and achieving optimisation for dental radiography
differs from the method for other x-ray applications, since dental units are used across large
numbers of facilities by personnel for whom radiological imaging is only a small componentof their speciality. Surveys of dental clinics show wide ranges in dose levels, because many
dentists have not changed their exposure times when switching to faster film or installing
digital radiography equipment, and have not set the shorter exposure times that would beappropriate for the more sensitive DR image receptors (Gulson, 2007; Holroyd, 2012; Farrisand Spelic, 2015).

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(279)
All dental facilities should measure the dose and imaging performance of x-ray
equipment at installation and at intervals, typically of three years, thereafter. Dental DRL
values are set for specific examinations using Ka,i as the DRL quantity. The radiation dose for
intraoral radiography is determined by the x-ray machine settings, selected in terms of tooth
type, linked to exposure time. In order to realise a dose reduction by changing to a moresensitive imaging detector, the x-ray equipment settings must be adjusted to alter the exposure
times. Based on test results, recommendations can be made on changes to equipment settings
and adjustments made in consultation with the dentists.

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(280)
Programmes involving regular testing of dental x-ray equipment andmeasurement of DRL quantities allow the identification of units with unnecessarily longexposure times. The investigator should work with the dentist to optimise protection.
Improvement in protection can be realised which otherwise might not be achieved. Martin(2016) has described an example of the reductions in dental doses achieved in the West of
Scotland through this approach. If there is no planned dose audit and optimisation programme,a substantial proportion of dental x-ray units are likely to continue to use exposure times
designed for older, less sensitive image detectors.

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7.1.3. Corrective action(281)
If an audit reveals that a DRL for any procedure is consistently exceeded (i.e.
the median value of the DRL quantity observed in the audit exceeds the DRL value), then an
investigation should be undertaken without undue delay, and appropriate corrective action
should be performed (EC, 2014).

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26

(282)
Corrective action (optimisation of protection) should include review of
equipment performance, the settings used, and the examination protocols (Martin, 2011).
Generally, it is easiest to check the x-ray system settings first, as this is less time consuming,then review of the examination protocols, and finally how the operators use the examination
protocols.

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29
30

(283)
As discussed in Section 2.6.2, when the median value of a DRL quantity at thefacility is lower than the median value of the benchmark national or regional DRL survey
distribution, image quality (or diagnostic information, when multiple images are used) should
be examined as a priority in the review.

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32
33
34
35
36
37

(284)
The audit process does not stop after a single assessment. Repeat surveys will
be required following any optimisation, and the whole process should be repeated after anappropriate time interval. For most radiography and diagnostic fluoroscopy examinations, a
representative selection of examinations for each x-ray unit should be surveyed at intervals of
about three years, and also when substantial changes in technology or software have been
introduced. Local audits of DRL quantities should be more frequent (annual) for CT andinterventional procedures. Annual audits are also appropriate for SPECT/CT and PET/CT.

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(285)
It is important that all dose audits are documented and that records aremaintained, so that knowledge of the optimisation processes undertaken is available for usersof the equipment in the future.

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7.2. Factors to consider if a DRL value is exceeded(286)
Clinical audit is a quality improvement process that seeks to enhance patientcare through systematic review and evaluation against explicit criteria, and implementation ofchange. Surveys of DRL quantities and comparisons with DRL values can help identify where
optimisation should be targeted.

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11
12
13
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15
16

(287)
As noted above, if a DRL value (and especially if a national DRL value) is
exceeded, this should be investigated without undue delay (Fig. 7.1). The outcome of theinvestigation should be to identify why the DRL value has been exceeded. In the body ofpatient data used to compare DRL values, there may be a number of patient cases where alarger amount of radiation was needed in order to achieve the image quality required toprovide the diagnostic information. If needed, remedial measures should be identified andinstituted prior to commencing the next audit cycle. The factors that are most likely to berequire remediation are:

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a. Survey methodology, including the performance of the survey instrument used andthe selection of patients included in the survey.
b. Equipment performance, including the imaging device, technical factors set by the
manufacturer or medical physicist, and film processing or digital reader.
c. Procedure protocol, relating to technique factors used at the facility.
d. Operator skill, including individual technique and operator training.
e. Procedure complexity and case mix, where patients within the group represent a
special category that makes the investigation more difficult, because of theirdisease, physical status or other reason.
(288)
Each of the preceding factors is discussed in more detail below. It is importantto remember that DRLs cannot be applied to judge the appropriateness of the radiation dose
for an individual patient. There is a much greater variation in the radiation dose for individual
patients than in median values of patient radiation dose at a facility.

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34

7.3. Survey methodology(289)
The first thing to be considered if the median value of the DRL quantity
exceeds the DRL value is whether the survey was carried out in a sound manner that wasconsistent with the way in which the DRL value was set in the first place. The types ofquestions that should be asked include the following.

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36
37
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39

a. Was the measurement device or system that was used calibrated correctly?
b. Were any TLDs that were used calibrated appropriately and were backgroundcorrections carried out correctly?
c. If a PKA meter was used, was it calibrated correctly for an undercouch tube or for
spot imaging? Alternatively, was the proper patient table attenuation factor for an

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d.
e.
f.
g.

undercouch tube applied to the PKA readings (PKA meters are usually calibrated
without the patient table in the beam)?
For CT scanners, were the CTDIvol or mAs values representative of the true valuesor (for tube current modulation) the average mAs set?
Were the displayed CT technique factors (e.g. kVp, slice thickness, CTDIw)
calibrated correctly?
Were all calculations performed using appropriate correction and calibration
factors and based on output measurements?
Were data for any patients who did not qualify for the group included
inadvertently (e.g. very large and very small patients)?

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7.4. Equipment performance(290)
Wherever new or more complex equipment has been installed, operators must
be made aware of, and trained in the use of, relevant dose saving technologies so that they canutilise the equipment effectively. Surveys of DRL quantities are recommended once operators
have established their new routines.

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(291)
The imaging equipment, or the manner in which it is set up, might be thereason why a national or regional DRL has been exceeded. Possible reasons for this relating
to different types of equipment are given in the following subsections.

19

7.4.1. Radiography and fluoroscopy(292)Radiography (general)

11

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26
27

Use of a lower tube potential than is required (Martin et al., 1993).
Use of an inappropriate grid.
Using a focussed grid at the wrong focus-to-image distance.
Use of a short focus-to-image receptor distance.
Use of a patient couch not designed for x-ray imaging or of an older design with ahigher attenuation.
(293)
Film radiography

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30
31
32

a.
b.
c.
d.
(294)

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35
36

a. AEC not set up correctly.
b. Use of a combination of CR/DR and film techniques in the same facility.
c. Differences in grid usage.
(295)
Mammography

37
38

a.
b.
c.
d.
e.

Slow speed (class ≤200) film-screen systems.
Different film-screen combinations.
Film not matched to the intensifying screen in the cassette.
Poor film processing.
Computed radiography (CR) or direct digital radiography (DR)a. Slow film-screen combination.
b. Suboptimal film processing.

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6

c.
d.
e.
f.
g.
(296)

Insufficient breast compression.
Grid used where not required.
AEC not set up correctly for digital mammography.
Manual exposure settings used instead of AEC.
Faulty detector.
Dental radiography

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11

a.
b.
c.
d.
(297)

Use of a slow speed film (D-speed rather than E or F).
Developer chemicals not changed frequently enough.
Development temperature incorrect.
Use of incorrect exposure settings for digital radiography.
Fluoroscopy and FGI procedures

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22

a. Old or outdated fluoroscopy equipment.
b. Image detectors from different manufacturers.
c. Incorrect dose programme options employed by equipment users or set by service
engineers, with too high an image receptor dose, exposure factors with too low akVp, too high a fluoroscopy pulse rate, or too high an image acquisition rate
(Martin and Hunter, 1994).
d. Copper or spectral filter options not properly set up or not utilised.
e. Inappropriate use of magnified field sizes that utilise higher dose rates.
f. Insufficient collimation.
g. Insufficient use of semi-transparent (triangular or wedge) filters.
h. Use of projections with unnecessarily steep gantry angulation.

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7.4.2. CT(298)
CT scanners are complex, and the interplay of many factors needs to be taken
into account. Optimisation requires close collaboration among radiologists, medical physicists
and radiographers who each have knowledge of different aspects of the imaging process.
Examples of some of the equipment factors involved are given below with possible ways inwhich controls might vary on different scanners. These factors will need to be specified inclinical protocols. These settings are discussed further in Section 7.5.2. CT scanners withsolid-state detectors are preferred to CT scanners with gas detectors (Fuchs et al., 2000).

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37

(299)
Images of thinner slices tend to be noisier, as they use fewer photons. The way
in which CT scanner controls are set depends on the manufacturer and model. On somescanners, the selection of thinner slices may result in noisier images, while other scanners
may maintain the same image quality by increasing the tube current (and so the amount ofradiation applied) when thinner slices are imaged. The behaviour may also depend on thestage at which the selection of image thickness is made. Thus, a choice of thinner image slices
than is required may increase patient dose.

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(300)
Different CT scanner manufacturers adjust scan parameters in different ways,
so it is important that staff have a proper understanding of the capabilities of their scanner andhow these function in practice. One example is the selection of the pitch of a helical scan.
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Some manufacturers (many GE and Toshiba models) maintain the same tube current (mAs
per rotation), so that extending the pitch will reduce dose and decreasing pitch will raise dose.
Other manufacturers (many Siemens and Philips models) adjust the tube current when thepitch is changed, to maintain a similar dose level.

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(301)
A tube potential of 120 kV has been used for many years for the majority of
CT scans. However, a lower tube potential can give better image quality and result in a lower
patient dose. A qualified medical physicist should be involved when changes in tube potential
are considered.

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(302)
All CT scanner manufacturers now include automatic tube current modulation,
which reduces the tube current and therefore the amount of radiation applied in regions oflower attenuation. Tube current may be adjusted for the scan both along the z-axis (length) of
the body and as the tube rotates around the elliptical cross section of the body. However,different manufacturers implement these systems in different ways. Some (e.g. GE andToshiba models) use a measure of image quality based on the noise level in the image. Suchsystems increase the tube current proportionately with the size of the patient. Other systems
use comparisons with a reference image or reference mAs, thus allowing a higher level ofnoise for larger patients (Siemens and Philips). The images from larger patients have better
separation of organs and other structures due to interposed fatty tissue, so a higher noise levelcan be tolerated without impairing diagnosis (Sookpeng et al., 2014).

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(303)
Most scanners use the x-ray attenuation of the topogram/scout for tube current
modulation planning. Hence, it is essential to keep protective devices out of the scan range or
to use them after the topogram/scout has been performed.

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31

(304)
Selection of other parameters, such as filter options, can affect the function of
the tube current modulation. The reconstruction kernel should match the resolution and image
noise requirements of the clinical task. A smooth filter will reduce noise, whereas a sharp
filter will accentuate boundaries, improving resolution but increasing noise. The appropriate
filter depends on the imaging task. On some CT scanner models, selection of a sharper filter
that increases the noise will cause the tube current modulation to increase the tube current andtherefore the amount of radiation in order to maintain the same noise level, while for otherscanner models the appearance of the image will change, but the amount of radiation willremain relatively unchanged (Sookpeng et al., 2015).

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35
36

(305)
Newer CT scanners have the ability to employ iterative image reconstruction
techniques. These require more computing power than conventional back projection methods,
but can reduce the amount of radiation considerably where they are applied. These techniquesshould be employed wherever available and practicable, and setting of lower DRL values
linked to the reconstruction technique should be considered.

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(306)
It is important for users to obtain detailed instruction in CT scanner operationfrom the manufacturer’s applications specialist at installation and for medical physics staff to110

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undertake tests to confirm the performance of relevant controls during the period whenclinical protocols are being set up.

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(307)
Because tube current modulation operates in different ways on different CT
scanner systems, the relationship between patient dose and patient size or weight varies. It is
recommended that surveys of DRL quantities for CT include measurements for patients ofdifferent sizes. This may be done by taking data for different weight groupings or through thefit of an exponential equation to DLP versus weight data (Järvinen et al., 2015). Alternatively
the patient diameter or the cross sectional area, either of which can be measured from thescanner display, may be recorded and used to group patients (Sookpeng et al., 2014). If data
are recorded either in a RIS or other patient dose management system, so that results for large
numbers of patients are available, then the 1st and 3rd quartiles may be recorded as well as
the median value (Martin, 2016). If data collection and patient size assessment are automated,then plots of DRL quantities such as CTDIvol, DLP or SSDE against a patient size factor may
be useful (Samei and Christianson, 2014). The method that is most appropriate will depend on
the local availability of hardware and software. Comparisons of the values of DRL quantities
among scanners, in addition to comparison to DRL values, can be useful in the evaluation.

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7.4.3. Nuclear medicine(308)
Since the DRLs for nuclear medicine are based on the activity administered,
the approach to optimisation is different in character from that used for the other imaging
modalities discussed in this report.

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(309)
When a facility consistently exceeds the recommended DRL value, it
represents a choice made by the clinician and the operator. If images are inadequate, this may
indicate that the imaging equipment is less than optimal and may require maintenance. If
equipment performance cannot be improved, then whether the equipment can and should be
replaced will involve issues of funding, the availability of alternatives, and the risks ofcontinuing with the current regime.

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(310)
If values of CTDIvol or DLP for the CT component of hybrid imaging (i.e.
PET/CT and SPECT/CT) are above the DRL value, then the purpose of the imaging task,
whether it is primarily a diagnostic test or performed for attenuation correction or positioning,should be considered.

31

7.5. Procedure protocols(311)
Clinical protocols should be reviewed and revised when new equipment isinstalled, in order to ensure that all available dose-saving technologies are used effectively.
Audit results should be taken into account when clinical protocols undergo periodic review.

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38

7.5.1. Radiography and fluoroscopy protocols(312)
There is general agreement on what constitutes good radiographic technique(EC, 1996a,b), so clinical protocols should have been standardised. Technique should not
generally be the cause of local or national DRL values being exceeded in radiography.

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However, technique-related data should be reviewed for any indication of why values for
DRL quantities might be high, such as use of too low a tube potential for examinations of thespine. Comparisons can be made with recommended techniques and exposure factors (EC,
1996a,b). Chest radiography requires imaging of both the low attenuation region of the lungs
and the high attenuation mediastinum. The appropriate exposure factors have been an area ofparticular study (ICRU, 1995).

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(313)
Examinations that involve fluoroscopy are less standardised. However, thefluoroscopy programme (protocol) determines the image receptor dose rate and the relative
rates at which tube current and potential are increased, and has a considerable influence on
both patient dose and image quality. The choice of copper filtration options to reduce skindose (i.e. spectral filtration), especially in interventional fluoroscopes, also has a significant
influence on patient dose.

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(314)
A review of technique may identify a need to improve a clinical protocol tofurther optimise protection. For the majority of procedures, technique is not a good reason
why a locally derived DRL value should be exceeded, and should not be a reason forincreasing a local DRL value. If a given protocol results in a higher value for one or more
DRL quantities (e.g. PKA), the protocol should be reviewed.

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26

7.5.2. CT protocols(315)
When median values of the DRL quantities for CT are too high or too low,
there are many possible reasons, so careful analysis of the clinical protocols and the scanner
settings is required. As discussed in Section 7.4.2, the ways in which controls affect patient
dose and image quality for CT scanner models from the various manufacturers are different,
so it is important that operators and medical physicists understand how the controls on their
particular scanner affect the imaging process (ICRU, 2012). Because CT scanner models are
so different, clinical protocols must never be transferred between CT scanners without
adjustment, unless the CT scanners are identical models.

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(316)
First, check whether the clinical imaging task for which the DRL has been set
is similar to one for which the scan is used. Then check whether DLP and CTDIvol are both
too high. If the DLP is high, but the CTDIvol is within the normal range, then the scanned
region may be longer than necessary or the number of scan sequences may be too great. A
common reason for higher values of DRL quantities is the use of scan sequences both without
and with enhancement with contrast material. Consideration should be given to whether thesesequences are all necessary for the clinical task in hand.

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35

(317)
reviewed:

36

a.
b.
c.
d.

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38
39

If both the DLP and CTDIvol are too high then these scan parameters should be
Slice thickness.
Beam collimation.
Geometric efficiency.
Tube voltage.
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e. Beam-shaping filter.
f. Is the helical pitch appropriate for the selected mAs?
g. Is the relationship of helical pitch and the mAs indicator understood?
h. Is the selected tube current modulation image noise indicator appropriate for theslice thickness?	
  

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(318)
The operation of tube current modulation has an important effect on patient
doses for individual patients, as discussed in Section 7.4.2. When CT protocols are set up, theprocess should take into account how the interaction of the different variables that can be set.
Tube current modulation systems that use noise as an image quality indicator may require thathigher noise levels be set for larger patients.

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13
14
15

(319)
The technique factors required for a CT examination and the resulting valuesof DRL quantities are dependent on patient size. Scans of larger patients may not require as
low a noise level, because there is better delineation of internal organs than in thin patients.
Each CT facility should establish specific scan protocols for different groups, based on patient
size:

16
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18
19

a. Paediatric patients: Weight, cross sectional area or age.
b. Adult patients within different weight ranges: Weight, equivalent diameter or crosssectional area.
c. Bariatric patients: Equivalent diameter or cross sectional area.

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(320)
Image quality should also be taken into account when median values of DRL
quantities are too high or too low. This is a complex multi-factorial task and some of thefactors involved are listed below:

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31
32
33
34
35
36
37

a.
b.
c.
d.

Image display (field of view, window level and width).	
  Spatial resolution (focal spot size and reconstruction kernel for filter).	
  Temporal resolution (rotation time, reconstruction mode).	
  Timing of contrast material bolus	
  (scan delay, rotation time and pitch).	
  7.5.3. Nuclear medicine protocols(321)
If the survey results exceed the local or national DRL value, but the imaging
equipment performance is adequate according to QA tests, then justification for the use of anactivity higher than the DRL value is a matter that requires discussion with the responsible
clinician.
7.6. Operator skill(322)
Use of appropriate protocols for individual examinations depends on theoperator’s knowledge, skill and training, especially where new technology has been
introduced. Practices of individual operators may vary, and staff with less experience may not
be as adept. Operator skill also extends to the awareness and management of dose-savingfeatures of the equipment.
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(323)
Variations in operator skill can result in large variations in values of DRL
quantities (e.g. PKA, Ka,r, CTDIvol, DLP) for the same procedure. Comparison of multiple
DRL quantities (Table 3.2) with local or national DRL values and among operators can bevaluable. For fluoroscopy, fluoroscopy time and the number of images in digital sequences
can provide an obvious comparator, while review of relative values for Ka,r and PKA will
provide additional information on the extent of beam collimation by different operators.
Similarly, comparison of both CTDIvol and DLP can be useful for CT.

8
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10
11

(324)
Radiographers perform barium enemas routinely in some healthcare facilities,
and suitably trained nurse practitioners can perform limited interventional procedures.
Clinical protocols should be refined before groups with less general medical or radiology
education than physicians are trained to carry them out.

12
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14
15
16
17

(325)
As operators gain more experience, patient doses may decrease to some extent.
Thus, results from surveys and comparisons between different operators, while useful, mustbe put into context and used appropriately to advise staff and contribute to improving
technique where appropriate. As the sophistication of the examination increases, the evidencebase shrinks. Different operators may employ different techniques to perform similar
procedures.

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23

(326)
Where median values for individual operators are found to be higher than forother operators, and especially when they exceed the DRL value, training on specificequipment may be necessary, particularly with respect to the dose saving features. Retrainingof operators will be required when new techniques have been introduced, but may also be
required when operators have developed bad habits that result in patient doses that are not
optimised.

24

7.7. Procedure complexity and case mix(327)
Case mix can be a factor at a facility for some examinations, meaning that it
may not be appropriate to compare DRL quantities for procedures performed in certain patient
populations with DRL values determined from surveys of the general population. Some
examples are:

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33
34
35
36
37
38
39
40

a. Patients with more complex clinical conditions or other specific patient groups
may be sent for interventional examination or treatment to a particular department
or hospital, resulting in more prolonged examinations and higher patient doses inthat department.
b. Expertise may lead to particular physicians carrying out the more difficult cases,
the consequence of which is that values of the DRL quantities for the proceduresthat they perform are higher.
c. Chest x rays in a specialist clinic may require a higher level of image quality forspecific diagnoses.
d. Other radiographs in a specialist clinic, obtained for specific indications, may
require additional views beyond those used typically.

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(328)
It may be appropriate for median values of DRL quantities from certain casemixes, such as in the examples above, to exceed the national DRL value. In such cases, aseparate local DRL value that is greater than the national/regional value could be set for thatenvironment, based on local surveys and taking into account the differences in patients andpractice.

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7.8. Outcome of the investigation(329)
Comparisons of local audit data to the national DRL value should trigger the
first step in the optimisation process and inform the responsible individuals where to prioritise
the optimisation effort. Once the investigation has revealed the reason(s) for any higher valuesof DRL quantities, remedial action needs to occur (Fig. 7.1). This should be within the context
of the risk management strategy of the organisation.

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(330)
Findings relating to deficiencies in equipment performance might reinforce theexpected outcome and provide further support for the case to replace equipment. However, if
the findings are unexpected, then a critical review of QA and maintenance programmes might
be required. Examples include:

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36

a. High values of DRL quantities for CR or DR might trigger adjustment of the AEC.
A qualified medical physicist should work together with the service engineer toadvise on and check the performance of the AEC.
b. For radiography, if the conclusion is that technique is responsible, then standard
operating procedures and protocols will have to be reviewed.
c. For fluoroscopy, the action taken will depend on the complexity of theexamination and findings of the subsequent investigation. Those involved should
review the technique critically and question the appropriateness of different
components.
d. For CT, it is likely that a review of the clinical protocol and the way in which thescanner controls are set is required. This is likely to require input from aradiologist, a medical physicist and a radiographer.
e. If the national DRL value is exceeded because of case mix, there is a sound reason
for increasing the local DRL.
(331)
Many dose savings can be made without affecting the image adversely.
However, patient dose must not be reduced so much that the images become non-diagnostic.
Dose reduction is not an end unto itself. The adequacy of the image is paramount. Image
quality must never be reduced to the point where there is a risk that it is not sufficient for the
medical imaging task. If it is suspected or possible that the diagnostic potential of the image
could be affected by any changes made, then appropriate tests must be undertaken to confirm
that this is not the case before the changes are implemented.

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(332)
Once optimisation of protection has been undertaken, a repeat survey should
be carried out to determine whether the DRL quantities have been brought down to an
appropriate level.

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7.9. References2
3EC, 1996a. European guidelines on quality criteria for diagnostic radiographic images. EUR
16260 EN. European Commission, Luxembourg.

45EC, 1996b. European guidelines on quality criteria for diagnostic radiographic images inpaediatrics. EUR 16261 EN. European Commission, Luxembourg.

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7
8
9
10

EC, 2013. Council Directive 2013/59/Euratom of 5 December 2013 laying down basic safety
standards for protection against the dangers arising from exposure to ionising radiation,and repealing Directives 89/618/Euratom, 90/641/Euratom, 96/29/Euratom,
97/43/Euratom and 2003/122/Euratom. Off J Eur Commun L13, 1-73. http://eurlex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2014:013:0001:0073:EN:PDF

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12
13

Farris, K., Spelic, D. Nationwide Evaluation of X‐Ray Trends: Highlights of the 2014‐15
NEXT Dental Survey. In: Proceedings of 47th National Conference on Radiation Control,
August 2015. CRCPD publication E-15-4, August 2015.

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15
16

Fuchs, T., Kachelriess, M., Kalendar, W.A., 2000. Direct comparison of a xenon and a solidstate CT detector system: measurements under working conditions. IEEE Trans. Med.
Imaging 19, 941–948.

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19

Gulson, A.D., Knapp, TA., Ramsden, P.G., 2007. Doses to patient arising from dental x-ray
examinations in the UK 2002-2004. A review of x-ray protection service data. HPARPD-022 (HPA: Chilton).

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21

Holroyd, J.R., 2012. Trends in dental radiography equipment and [atient dose in the JK and
Ireland. HPA-CRCE-043 (HPA: Chilton).

22

ICRU, 2003. Image quality in chest radiography. Report 70. J. ICRU 3, 1–165.

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ICRU, 2012. Radiation dose and image quality and image-quality assessment in computed
tomography. Report 87. J. ICRU 12, 1–149.

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IPEM, 2004. Guidance on the establishment and use of diagnostic reference levels for medical
X-ray examinations. IPEM Report 88. Institute of Physics and Engineering in Medicine,
York.

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IPSM/NRPB/CoR, 1992. National protocol for patient dose measurements in diagnostic
radiology. National Radiation Protection Board, Chilton.

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Järvinen, H., Seuri, R., Kortesniemi, M., Lajunen, A., Hallinen, E., Savikurki-Heikkilä, P.,
Laarne, P., Perhomaa, M., Tyrväinen, E., 2015. Indication based national diagnostic
reference levels for paediatric CT: a new approach with proposed values. Radiat. Prot.
Dosim. 165, 86–90.

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Martin, C.J., Darragh, C.L., McKenzie, G., Bayliss, A.P., 1993. Implementation of aprogramme for reduction of radiographic doses and results achieved through increases intube potential. Brit. J. Radiol. 66, 228–233.

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Martin, C.J., Hunter, S., 1994. Reduction of patient doses from barium meal and barium
enema examinations through charges in equipment factors. Brit. J. Radiol. 67, 1196–1205.
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Martin, C.J., 2011. Management of patient dose in radiology in the UK. Radiat. Prot. Dosim.
147, 355–372.

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Martin, C.J., 2016. The application of diagnostic reference levels for optimisation of x-ray
imaging in the UK. Radiat. Prot. Dosim. (in press, doi: 10.1093/rpd/ncv433).

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7Martin, C.J., Le Heron, J., Borrás, C., Sookpeng, S., Ramirez, G., 2013. Approaches to
aspects of optimisation of protection in diagnostic radiology in six continents. J. Radiol.
Prot. 33, 711–734.

89Samei, E., Christianson, O., 2014. Dose index analytics: more than a low number. J. Am.
Coll. Radiol. 11, 832–834.

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Sookpeng, S., Martin, C.J., Gentle, D.J., Lopez-Gonzalez, M.R., 2014. Relationships between
patient size, dose and image noise under automatic tube current modulation systems. J.
Radiol. Prot. 34, 103–123.

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Sookpeng, S., Martin, C.J., Gentle, D.J., 2015. Investigation of the influence of image
reconstruction filter and scan parameters on operation of automatic tube current
modulation systems for different CT scanners. Radiat. Prot. Dosim. 163, 521–531.

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8.

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10.

SUMMARY OF THE COMMISSION’S RECOMMENDATIONS

8.1. General
Diagnostic reference levels (DRLs) should be used to evaluate whether, in routine
circumstances, the amount of ionising radiation applied for a medical imaging
procedure at a local healthcare facility, when assessed for a representative sample ofstandard-sized patients (not individual patients) for a defined clinical task, is too highor too low. The DRL process allows identification of equipment and procedures forwhich radiation dose levels are high, so that optimisation of protection can beundertaken.
A DRL value is considered to be exceeded when the local median value of a DRL
quantity for a representative sample of standard-sized patients is greater than the local,
national, or regional DRL value.
DRLs may be established by authorised bodies. The numerical values of DRLs areadvisory. However, an authorised body may require implementation of the DRL
concept.
Organisations responsible for different components of the tasks of collating data on
DRL quantities and setting national DRLs should be identified in each country or
region.
DRLs should not be used to evaluate medical imaging tasks where the relative tissue
dose distribution in the body is appreciably different from that of the medical imaging
task used to establish the DRL.
DRL values shall not be used for individual patients or as trigger (alert or alarm) levels
for individual patients or individual examinations.
Comparison of local practices to DRL values is not sufficient, by itself, for
optimisation of protection. Image quality or, more generally, the diagnostic
information provided by the examination (including the effects of post-processing),
must be evaluated as well, and methods to achieve optimisation should be
implemented.
All individuals who have a role in subjecting a patient to a medical imaging procedure
should be familiar with DRLs as a tool for optimisation of protection.
The concept and proper use of DRLs should be included in the education and training
programmes of the health professionals involved in medical imaging with ionisingradiation.
8.2. DRL quantities
Quantities used for DRLs should assess the amount of ionising radiation applied toperform a medical imaging task, and should be easily measured or determined. DRL
quantities assess the amount of ionising radiation used for a medical imaging

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11.
12.

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14.

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15.

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21.

procedure, not absorbed dose to a patient or organ. The one exception ismammography, for which mean glandular dose (DG) may be used.
DRL quantities should be appropriate to the imaging modality being evaluated.
The Commission stresses that effective dose (radiological protection quantity used forother purposes in the ICRP system of radiological protection) should not be used as a
DRL quantity. It introduces extraneous factors that are neither necessary nor pertinent
for the purpose of a DRL.
For projection radiography, two DRL quantities are recommended: entrance surface
air kerma, Ka,e (or incident air kerma, Ka,i), and kerma-area product (PKA), in order tosimplify assessing proper use of collimation, especially in paediatrics.
DRLs developed for advanced radiographic techniques (e.g. tomosynthesis, dualenergy subtraction, contrast-enhanced subtraction, cone-beam computed tomography)
need to take into account the ‘multiple image’ aspect of the technique and should
distinguish these procedures from more standard procedures.
For mammography, the recommended DRL quantity is one or more of incident air
kerma (Ka,i), entrance surface air kerma (Ka,e), and mean glandular dose (DG), withthe choice of quantity depending on local practices.
For mammography, a simple approach could be setting DRLs for breasts of 5.0 cm ±0.5 cm thickness. Establishing DRLs for different breast thicknesses is a more
complex but better approach to refine DRLs for mammography.
For interventional radiology, all of the following DRL quantities are recommended (ifavailable): air kerma-area product (PKA), cumulative air kerma at the patient entrance
reference point (Ka,r), fluoroscopy time, and the number of radiographic images (e.g.
cine images in cardiology and digital subtraction angiography images in vascular
procedures).
The recommended DRL quantities for CT are volume-weighted computed tomographydose index (CTDIvol) and dose length product (DLP). The number of scan sequencesin the examination may be helpful as well. Size-specific dose estimates (SSDE) may
be used in addition.
The recommended CTDIvol value is the CTDIvol for each sequence. The recommended
DLP value is the cumulative DLP for the entire examination. DLP values forindividual scan sequences can be useful as well, and may be used in addition to the
cumulative DLP.
For nuclear medicine, the appropriate DRL quantity is the administered activity per kg
body weight of a specific radionuclide for a specific clinical task and, if relevant, theradiopharmaceutical used. Setting a fixed maximum administered activity for veryobese patients may also be considered. It is recognised that in many countries, astandard activity is used in clinical practice for adult patients.
Weight-based administered activities may not be appropriate for examinations where
the radiopharmaceutical is concentrated predominantly in a single organ (e.g. thyroid
scans, lung perfusion scans).
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22.

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6

23.

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9
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24.

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25.

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26.

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27.

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28.

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29.

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30.

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31.

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39

32.

Since DRLs for nuclear medicine procedures and CT procedures apply to radiationfrom very different modalities, and use different DRL quantities, for hybrid imaging
procedures, it is appropriate to set and present DRL values for each modality
independently.
8.3. Use of median values of the DRL survey distribution
Compliance with DRLs does not indicate that the procedure is performed at an
optimised level with regard to the amount of radiation used. The Commission
recognises that additional improvement can be obtained by using the median value(the 50th percentile) of the distribution used to set the national or regional DRL value.
This median value can serve as an additional tool to aid in optimisation, and may be adesirable goal at which to aim using standard techniques and technologies, andrepresents a more optimum use of the applied radiation.
When the facility’s median value of a DRL quantity is lower than the median value ofthe national or regional DRL survey distribution, image quality (or diagnostic
information, when multiple images are used) may be adversely affected and should beconsidered as a priority in the review.
8.4. DRL surveys
The Commission recommends setting local and national DRL values based on surveysof the DRL quantities for procedures performed on appropriate samples of patients.
The use of phantoms is not sufficient in most cases. When phantoms are used, theeffects of operator performance, the selected imaging protocol, and patient variability
are not taken into account.
The use of phantoms is important in the investigation of x-ray equipment performance,
and is important in evaluating the performance of fluoroscopy and CT equipment withrespect to the amount of radiation used during the optimisation of protection.
Calibrations of all dosimeters, kerma-area product meters, etc., used for patient
dosimetry should be performed regularly and should be traceable to a primary or
secondary standard laboratory.
The accuracy of DRL quantity data produced by and transferred from x-ray systems
should be periodically verified by a medical physicist.
The examinations/procedures included should, in general, represent the most frequentexaminations performed in the region for which dose assessment is practicable, withpriority given to those that result in the highest patient radiation dose.
National surveys for setting DRLs should normally include medium- and large-sized
healthcare facilities that have a sufficient workload to ensure that data for arepresentative selection of patients can be obtained. The sample should also cover therange of healthcare providers.
For large countries, a survey of a random selection of a small proportion of all thehealthcare facilities in the country can provide a good starting point for setting120

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33.

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35.

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36.

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37.

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38.

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39.

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40.

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41.

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42.

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national DRLs. Results from 20-30 facilities are likely to be sufficient in the first
instance. In a small country with fewer than 50 facilities, an initial survey of 30%-50%of them may suffice.
A survey for a particular examination in a facility should normally involve collectionof data on DRL quantities for at least 10-20 patients, and preferably 20-30 for
diagnostic fluoroscopy examinations and 50 patients for mammography. For
paediatrics, these figures may need to be decreased for facilities where relatively few
children are examined.
There should be some standardisation of weight for adult patients included in surveys
of diagnostic procedures if data are collected from fewer than 50 patients, e.g. patientswith weights between 60 kg and 80 kg for a mean weight of 70 kg ± 5 kg.
Hospital Information Systems and Radiology Information Systems can provide data
for large numbers of patients. As with all DRL surveys, the results rely on theaccuracy of data entry, and may not include patient weight.
Radiology Information Systems and associated software may permit data on DRL
quantities to be obtained in an automated fashion. When automated processes are used,the data for all cases of a specific procedure should be obtained and used for
optimisation.
8.5. Setting DRL values
The numerical value of the DRL should be tied to defined clinical and technicalrequirements for the selected medical imaging task.
The appropriate image quality or diagnostic information needed for the clinical task
should be the priority when setting DRLs. DRLs may differ for different clinical tasks,
especially for CT.
It is important when developing DRLs that all data collected come from similar
procedures across all participating facilities. This ensures that comparisons among
facilities remain valid and useful.
It may be important to specify in detail the views normally included and the clinicaltask associated with the procedure. This may be required where differing exposure
factors or different views (or numbers of views) are employed for different clinicalindications.
When two imaging modalities are used for the same procedure (e.g. PET/CT,
SPECT/CT), it is appropriate to set and present DRLs for both modalities
independently.
DRL values are dependent on the state of practice and the available technology(including post-processing software) at a particular point in time.
Median values (not mean values) of the distributions of data collected from a
representative sample of standard-sized patients should be used for comparison to
DRLs. The mean can be affected substantially by a few high or low values.

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44.

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48.

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50.

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51.

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52.

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53.

National DRLs should be set as the 75th percentile of median values obtained in asample of representative centres.
If regional (multinational) DRLs are created, they should be set as the median value ofthe national DRLs (each of which is set at the 75th percentile) for the countries in theregion. If the sample of available data is small, other approaches may be used byagreement among the involved countries.
The process to set and update DRLs should be both flexible and dynamic. Flexibility
is necessary for procedures where few data are available (e.g. interventional
procedures in paediatric patients), or from only one or a few centres. A dynamic
process is necessary to allow initial DRLs to be derived from these data while waiting
for a wider survey to be conducted.
When a procedure is not performed on a regular basis in most hospitals, local DRL
values may be determined using the data from a single large hospital with a relevant
workload of procedures (e.g. a specialised paediatric hospital).	
  Local DRLs set by a group of radiology departments or even a single facility can playa role, where effort has already been invested in optimisation. The group could set a
local DRL value based on more regular surveys of local practice that will normally belower than any national DRL value. Local DRL values can also be set for newer
technologies that enable lower dose levels to be used in achieving a similar level ofimage quality.
8.6. DRLS for interventional procedures
The Commission recommends retaining the term “diagnostic reference level” for the
DRL process as applied to interventional procedures.
For interventional procedures, complexity of the procedure may be considered insetting DRLs and a multiplying factor for the DRL value (e.g. 2, 3 or more) may beappropriate for more complex cases of a procedure.
If possible, the data from all interventional procedures performed (not just from alimited sample) should be collated to derive local and national DRLs.
8.7. Paediatric DRLs
A single ‘representative patient’ should not be used to define DRLs for paediatricimaging, since weight in children can vary by a factor of more than 100 from apremature infant to an obese adolescent.
The amount of administered radiation for examinations of children can varytremendously due to the great variation in patient size and weight, from neonates toadult-sized adolescents. This variation in patient radiation dose is appropriate.
Variation in patient radiation dose due to incorrect technique or failure to adapt theimaging protocol from adults to children to account for both paediatric diseases andpaediatric patient size is not appropriate.

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154.

Appropriate weight bands (generally with 10 kg intervals) are recommended forestablishing paediatric DRLs and should be promoted for paediatrics. Age bands (<1y; 1-<5 y; 5-<10 y and 10-<16 y and older ages, if appropriate, in another additionalgroup) can be used if age is the only available measure.

55.

For CT, the DRL quantities are CTDIvol and DLP, based preferably on calibration witha 32 cm phantom for body examinations and a 16 cm phantom for head examinations.
Values for these quantities should be obtained from patient examinations. Sizespecific dose estimates (SSDE) may be used as an additional source of information for
optimisation.
Modern CT scanners permit determination of effective diameter or patient equivalent
thickness. This should be considered as an additional refinement for setting paediatric
DRLs.
For nuclear medicine imaging, administered activities should be adjusted based onagreed factors linked to size or weight. This is especially relevant for paediatrics.

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60.

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62.

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63.

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64.

8.8. Application of DRLs in clinical practiceNational and regional DRL values should be revised at regular intervals (3-5 years) ormore frequently when substantial changes in technology, new imaging protocols or
post-processing of images become available.
Median values of the DRL quantity for medical imaging procedures in a representative
sample of standard-sized patients for a specific x-ray room, radiology department, orother facility should be compared with local, national or regional DRL values to
identify whether the data for that location are substantially higher or lower than might
be anticipated.
If a local or national DRL value for any procedure is exceeded, an investigation should
be carried out without undue delay, and appropriate corrective action should be taken.
When corrective action is required, it is necessary to keep in mind that DRL values are
not dose limits.
Corrective action (optimisation of protection) should include a review of equipment
performance, the settings used, and the examination protocols. The factors most likely
to be involved are survey methodology, equipment performance, procedure protocol,
operator skill and, for interventional techniques, procedure complexity.
In the optimisation process, account must always be taken of the level of image quality
required for the medical imaging task. Image quality must always be adequate toprovide the information required for the clinical purpose of the examination.
When a facility’s median value of a DRL quantity is too low, image quality (ordiagnostic information, when multiple images are used) may be affected adversely.
Image quality should be examined as a priority when the examination protocol isreviewed.

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67.

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68.

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69.

The DRL audit process does not stop after a single assessment. Repeat surveys are
required following any optimisation, and the whole process should be repeated after anappropriate time interval.
Local surveys of DRL quantities should normally be carried out as part of the clinicalaudit. A representative selection of examinations for each x-ray unit should besurveyed at intervals of about three years, and whenever substantial changes intechnology or software have been introduced.
Local surveys of DRL quantities, as part of the clinical audit, should be performed
annually for CT and interventional procedures. Annual surveys are also appropriate aspart of the clinical audit for SPECT/CT and PET/CT.	
  
If continuous collection of data on DRL quantities is possible through automatedcollation of data from electronic databases, then the dose management process may
take the form of a regular review of all the data to identify any adverse trends.
The method for managing and achieving optimisation for dental radiography differsfrom the method for other x-ray applications. Dental DRL values are set in terms ofincident air kerma measured during routine tests. Based on test results,
recommendations can be made on changes to equipment settings and adjustments.
The investigator should work with the dentist to optimise protection. Improvement inprotection can be realised which otherwise might not be achieved.

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Annex A.

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Key Points
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•

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•

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•

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PREVIOUS ICRP RECOMMENDATIONS ON DRLS••

DRLs are used in the optimisation of radiological protection in medicine. A DRL is aform of investigation level to identify unusually high (or low) levels, which calls for
local review if consistently exceeded (or below).
DRLs should be used by regional, national and local authorised bodies.
Implementation of the DRL concept may be required by an authorised body.
The numerical value of a DRL is advisory. The numerical value is not for regulatory
or commercial purposes, not a dose constraint, and not linked to limits or constraints.
The concept of DRLs allows flexibility in their selection and implementation.
The Commission’s previous advice did not specify quantities, numerical values ordetails of implementation for DRLs. This has been the task of the regional, national
and local authorised bodies, each of which should meet the needs in its respectivearea.
The rationale for the previous advice was that any reasonable and practical
approach, consistent with the advice, will improve the management of patient doses
in medical imaging.
A.1. Introduction

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(A1) Previously, advice was provided to regional, national and local authorised bodies andthe clinical community on the application of DRLs as a practical tool in diagnostic radiology
and nuclear medicine (ICRP, 2001). Achieving acceptable image quality or adequate
diagnostic information, consistent with the medical imaging task, is the overriding clinicalobjective. DRLs are then used to help manage the radiation dose to patients so that the dose iscommensurate with the clinical purpose. At that time, a review was conducted of the various
approaches that had been taken by authorised bodies, working in concert with professional
medical groups, to establish DRLs for medical imaging tasks. While the approaches were notuniform in aim and methodology, it was concluded that there were a variety of ways toimplement the concept of DRLs, depending on the medical imaging task of interest, theregional, national or local state of practice, and the regional, national or local preferences fortechnical implementation.

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(A2) The existing ICRP guidance was briefly reviewed, the approaches that had been taken
were summarised, and additional advice was presented (ICRP, 2001). The advice given thenprovided a framework for DRLs that was consistent with earlier ICRP guidance, but allowed
more flexibility in their selection and use. While some illustrative examples were given, theadvice did not specify the quantities to be used, the numerical values to be set for thequantities, or the technical details of how regional, national or local authorised bodies should
implement DRLs. A review and summary of that information are given here.

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A.2. Existing ICRP guidance

12
3(A3) Publication 60 (ICRP, 1991) provided the following recommendation in the section on
optimisation of protection in medical exposure in paragraph (S34):

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“Consideration should be given to the use of dose constraints, or investigation levels,
selected by the appropriate professional or regulatory agency, for application in somecommon diagnostic procedures. They should be applied with flexibility to allow higher
doses where indicated by sound clinical judgment.”.

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(A4) Publication 73 (ICRP, 1996) introduced the term “DRL”, explained its place in the
broader ICRP concept of reference levels, and expanded the Publication 60 recommendationin (S34) in more detail [paragraphs (99) through (106) of Publication 73]. The main points are
summarised below.

12(a) The term used is DRL.

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(b) DRLs are a form of investigation level, intended for use as a simple test to identify
situations where levels of patient dose are unusually high. If it is found that procedures are
consistently causing the relevant DRL to be exceeded, there should be a local review ofthe procedures and equipment in order to determine whether protection has beenadequately optimised. In principle, there could also be a lower level (i.e. below which
there is insufficient radiation dose to achieve a suitable medical image).

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(c) DRLs are supplements to professional judgment and do not provide a dividing line
between good and bad medicine. It is inappropriate to use them for regulatory orcommercial purposes. They are not a dose constraint, and not linked to limits orconstraints. The numerical value of a DRL is advisory.

2324(d) The examination types include diagnostic radiology and nuclear medicine (i.e.
common exams and broadly defined types of equipment).

2526(e) Their selection is by professional medical bodies, using a percentile point on theobserved distribution for patients, and specific to a country or region.

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(f) The quantities should be easily measured, such as absorbed dose in air or tissue
equivalent material at the surface of a simple standard phantom or representative patientfor diagnostic radiology, and administered activity for diagnostic nuclear medicine.

30

A.3. Previous review of reference levels in medical imaging

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(A5) Previously, there had been a number of approaches to reference levels (the earlier
terminology for DRLs) used for medical imaging. Typically, reference levels were used as
investigation levels (i.e. a QA tool), and their numerical values were advisory. However,authorised bodies could require implementation of the concept of a DRL.

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(A6) There had been fairly consistent criteria for selecting reference levels, although thecriteria used at that time differed for diagnostic radiology and nuclear medicine (and still do).
In diagnostic radiology, reference levels usually had been derived from distributions of
dosimetric quantities for patients observed in practice in the relevant region or country.
Usually, only upper levels were defined, and lower levels were not specified. In nuclear
medicine, reference levels were usually derived from pragmatic values of administeredactivity based on accepted custom and practice. Typically, all reference levels were developed
through cooperation between authorised bodies and professional groups or specialists (i.e.
clinical peer involvement).

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(A7) There had been different aims for various reference levels. While reference levels
apply to a selected medical imaging task, often the clinical and technical conditions were notfully defined, with the degree of definition dependent on the aim. At least three general aims
could be identified:

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(a) To improve a regional, national or local distribution observed for a general medical
imaging task, by identifying and reducing the number of unjustified high or low values inthe distribution;17(b) To promote good practice for a more specific medical imaging task; and18(c) To promote an optimum range of values for a specified medical imaging protocol.

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(A8) There had been a number of different quantities used for reference levels. The quantity
selected was dependent on the type of clinical procedure, for example, whether it was anindividual radiographic projection, a procedure or examination consisting of multiple
projections or field locations, or a diagnostic nuclear medicine procedure (i.e. a specificradiopharmaceutical and clinical purpose). The quantity used was also dependent on the bodysetting the reference level, and was related to the desired aim, local preference and the unique
irradiation conditions.

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(A9) The observations given above highlight the array of considerations and approaches toreference levels, whose features were displayed in Table 1 (Approaches to Reference Levels)
and Table 2 (Listing of Reference Levels) of ICRP Supporting Guidance 2 (ICRP, 2001).
Tables 1 and 2 listed approaches and values that had been selected by a number of authorisedbodies prior to that time. Tables 1 and 2 were for background information and were not partof the additional advice given in ICRP (2001) and in this recap.

32

A.4. Underlying considerations

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(A10)
In order to interpret correctly the relationship between a change in the
numerical value of a quantity used as a DRL and the corresponding change in patient tissue
doses that determine the relative patient risk, the following considerations are important:

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12(a) The numerical value of the DRL should be tied to defined clinical and technicalrequirements for the medical imaging task. The requirements can be general or specific.

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(b) The relative tissue dose distribution in the body should not change appreciably among
patients undergoing the selected medical imaging task. A proportional change in themeasured quantity should correspond to a proportional and uniform percentage change in
the individual tissue doses. If the relative tissue-dose distribution in the body isappreciably different from that used to establish the DRL, due to a different field size,
field location, beam quality or other technical factor that alters the internal dose
distribution, then interpretation of a change in the measured quantity with regard to thechange in tissue doses (and therefore the patient risk) would be ambiguous. In setting
DRLs, regional, national and local authorised bodies and professional groups should becognizant of these considerations.

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A.5. Advice on DRLs provided in ICRP (2001)

14

A.5.1. Objective of a DRL

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(A11)
The objective of a DRL is to help avoid radiation DRL quantity to the patientthat does not contribute to the clinical purpose of a medical imaging task. This isaccomplished by comparison between the numerical value of the DRL (derived from relevant
regional, national or local data) and the mean or other appropriate value observed in practicefor a suitable reference group of patients or a suitable reference phantom. A reference groupof patients is usually defined within a certain range of physical parameters (e.g. height,
weight). If an unselected sample of patients were used as a reference group, it would be
difficult to interpret whether the observed value for the sample is higher or lower than the
DRL. A DRL is not applied to individual patients.

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A.5.2. Uses for a DRL

25

(A12)

A DRL can be used:

2627(a) To improve a regional, national or local distribution of observed results for a general
medical imaging task, by reducing the frequency of unjustified high or low values;

2829(b) To promote attainment of a narrower range of values that represent good practice for amore specific medical imaging task; or3031(c) To promote attainment of an optimum range of values for a specified medical imaging
protocol.

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(A13)
A “general imaging task” is an imaging task performed for a general clinicalpurpose, with minimum specification of other factors e.g. a posteroanterior (PA) chest

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radiograph with the clinical purpose and technique factors unspecified. A “more specificmedical imaging task” is an imaging task for a clearly defined clinical purpose, but withallowance for differences among medical facilities in other technical and clinical details, e.g.
a PA chest radiograph with the clinical purpose and the general technique (such as high kVp)
specified, but the detailed technique factors unspecified. A “specified medical imaging
protocol” is a clinical protocol with a fully defined set of specifications that is followed, or
serves as a nominal baseline, at a single facility (or several allied facilities), e.g. a protocol fora PA chest radiograph that specifies the clinical purpose, the technical conduct of theprocedure, the image quality criteria, any unique patient characteristics, and other appropriate
factors. Uses (a), (b) and (c) are differentiated by the degree of specification for the clinicaland technical conditions selected by the authorised body for a given medical imaging task.

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15

(A14)
Appropriate local review and action are taken when the value observed inpractice is consistently outside the selected upper or lower level. This process helps avoid
unnecessary tissue doses being received by patients in general and, therefore, helps avoid
unnecessary risk for the associated radiation health effects.

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A.5.3. Definitions and examples

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21

(A15)
This section provides the examples of quantities and their application to DRLs
previously given by the Commission (ICRP, 2001) for the uses referred to in Section 2.5.2.
The examples do not constitute recommendations; however, they illustrate generally theadvice. More focussed discussions of desirable quantities for various medical imaging
modalities are found in the relevant chapters of this report.

22
23

(A16)
Examples of quantities and their application to improve a regional, national or
local distribution of observed values for a general medical imaging task are:24
25(a) Incident air kerma (in air, no backscatter) (Ka,i) or entrance-surface air kerma (in air,with backscatter) (Ka,e) in mGy, for a given radiographic projection (e.g. PA chest);

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28

(b) Air kerma-area product (PKA) in Gy·cm2 or mGy·cm2 for a given type of fluoroscopic
examination that has a well-defined anatomical region of clinical study (e.g. barium
enema); and

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31

(c) Administered activity (A) in MBq for a given nuclear medicine imaging task using agiven radiopharmaceutical [e.g. lung perfusion with Tc-99m macroaggregated albumin(MAA)].

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(A17)
Examples of quantities and their application to promote attainment of anarrower range of values that represent good practice for a more specific medical imaging
task are:3536(a) Incident air kerma (in air, no backscatter) (Ka,i) or entrance-surface air kerma (in air,with backscatter) (Ka,e) in mGy, for a specific radiographic imaging task. The clinical129

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purpose is defined, but the x-ray equipment, technique factors, and image quality criteria
may vary among facilities;

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(b) Air kerma-length product (PKL) in mGy·cm for a given type of computed tomography(CT) examination that has a well-defined anatomical region of clinical study (e.g. routine
abdominal CT scan), with specified clinical objective, image quality criteria and technicalfactors. The x-ray equipment (i.e. the CT system) may vary among facilities; and

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(c) Air kerma-area product (PKA) in mGy·cm2 for a specific fluoroscopic examination. The
clinical purpose is clearly defined, but the type of equipment, technique factors and patientcharacteristics may differ within or among facilities. The relative tissue dose distribution
is expected to be minimally variable, such that a proportional change in PKA corresponds
to a nearly proportional change in absorbed dose for each of the irradiated tissues.

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13

(A18)
Examples of quantities and their application to promote attainment of an
optimum range of values for a specified medical imaging protocol are:1415(a) Tube potential (kVp) for a specific CT protocol. The clinical purpose, type ofequipment, technique factors and patient characteristics are defined.

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(b) Administered activity (A) in MBq for a specific imaging protocol using a specificradiopharmaceutical for SPECT. The clinical purpose, type of equipment, techniquefactors and patient characteristics are defined.

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A.5.4. Note on fluoroscopically-guided interventional procedures

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26
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(A19)
For FGI procedures, DRLs, in principle, could be used to promote themanagement of patient doses with regard to reducing the probability of stochastic radiation
effects. However, the observed distribution of patient doses is very wide, even for a specified
protocol, because the duration and complexity of the fluoroscopic exposure for each conductof a procedure are strongly dependent on the individual clinical circumstances. A potential
approach is to take into consideration not only the usual clinical and technical factors, but also
the relative “complexity” of the procedure. More than one quantity (i.e. multiple DRLs) may
be needed to evaluate patient dose and stochastic risk adequately.

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(A20)
DRLs are not applicable to the management of tissue reactions (e.g. radiationinduced skin injuries) from FGI procedures. In this case, the objective is to avoid tissue
reactions in individual patients undergoing justified, but long and complex procedures. The
need here is to monitor in real time whether the threshold doses for tissue reactions are being
approached or exceeded for the actual procedure as conducted on a particular patient. The
relevant risk quantity is absorbed dose in the skin at the site of maximum cumulative skindose. A helpful approach is to select values for maximum cumulative absorbed dose in theskin at which various clinical actions regarding the patient’s record or care (related topotential radiation-induced skin injuries) are taken (ICRP, 2000). Then, during actual
procedures, appropriate quantities that can help indicate the maximum cumulative absorbed
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dose in the skin are monitored [The Commission has since provided advice on monitoring
maximum cumulative absorbed dose in the skin (peak skin dose) (ICRP, 2013)].

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A.5.5. Local flexibility in setting DRLs

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5

(A21)
DRLs should be used by authorised bodies to help manage the radiation doseto patients so that the dose is commensurate with the clinical purpose.

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(A22)
The concept of a DRL permits flexibility in the choice of quantities, numericalvalues, and technical or clinical specifications, in order to allow authorised bodies to meet theobjectives relevant to their circumstances. The guiding principles for setting a DRL are:910(a) The regional, national or local objective is clearly defined, including the degree of
specification of clinical and technical conditions for the medical imaging task;

11(b) The selected value of the DRL is based on relevant regional, national or local data;

12(c) The quantity used for the DRL can be obtained in a practical way;

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15

(d) The quantity used for the DRL is a suitable measure of the relative change in patient
tissue doses and, therefore, of the relative change in patient risk for the given medical
imaging task; and16(e) The manner in which the DRL is to be applied in practice is clearly illustrated.

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(A23)
Authorised bodies, in conjunction with professional medical bodies, areencouraged to set DRLs that best meet their specific needs and that are consistent for theregional, national or local area to which they apply.
A.6. References
ICRP, 1991. 1990 Recommendations of the International Commission on RadiologicalProtection. ICRP Publication 60. Ann. ICRP 21(1–3).
ICRP, 1996. Radiological protection and safety in medicine. ICRP Publication 73. Ann. ICRP
26(2).
ICRP, 2000. Avoidance of radiation injuries from interventional procedures. ICRP
Publication 85. Ann. ICRP 30(2).
ICRP, 2001. Diagnostic reference levels in medical imaging: Review and additional advice.
ICRP Supporting Guidance 2, Ann. ICRP 31(4).
ICRP, 2013. Radiological protection in cardiology. ICRP Publication 120. Ann. ICRP 42(1).

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